Meridian Bioscience, Inc（CMS # 720826）

Issuing Office:

Center for Devices and Radiological Health

United States

WARNING LETTER
CMS # 720826

December 22, 2025

Dear Mr. Serafini-Lamanna:

During an inspection of your firm, Magellan Diagnostics, Inc. located in North Billerica, MA from August 5, 2025, through August 26, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in-vitro diagnostics (IVD) kits that measure blood lead levels, including the LeadCare II Blood Lead Analyzer and Test Kit. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Quality System Regulation Violations
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received responses from Vernon Brown Director – Quality Assurance and Regulatory Affairs, Meridian Biosciences, Inc. dated September 17, 2025, October 3, 2025, October 17, 2025, November 14, 2025, November 26, 2025, and December 12, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address your responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a).

Specifically, your firm failed to follow its CAPA procedure, SOP 128, Rev 15, Effective March 27, 2025, including opening CAPAs as required by your procedure. Section 2 of this SOP indicates CAPA’s can arise from “A systemic issue identified through trend monitoring.” For example:

A) Your firm failed to open a CAPA in October 2024, when you began trending an increase in patient false positive complaints (PATFP) associated with the use of certain third-party ((b)(4)) collection tubes used with your LeadCare II Blood Lead Test Kit. From October 7, 2024, to August 14, 2025, you identified approximately 179 of these PATFP complaints. We are also aware that you did not take these complaints into account with a previous CAPA 1288 which was initiated on May 3, 2023, to address increased patient false positive complaints (PATFP) for the LeadCare II Blood Lead Test Kit. This CAPA 1288 was closed out on May 22, 2025, noting that “current complaint trending reports confirm that the PATFP complaint rate has reached a steady state.” However, your firm received 31 complaints of false positives after this date and did not take any further action, such as the opening of a new CAPA, as required by your procedure.

B) Your firm failed to open a CAPA to address at least (b)(4) out-of-range control complaints ("COORLO") received for your LeadCare II Blood Lead Test Kit from June 22, 2021, to July 2025.

We reviewed your firm’s responses and concluded they are not adequate. We understand that you have revised product labeling to indicate that the customer must use only the capillary tubes included in the LeadCare II Blood Lead Test Kit for blood collection and that you plan to send customers a letter to inform them of this update. Please be aware that this action would require a report to be submitted to FDA as required by 21 CFR 806. However, your firm has not provided copies of the CAPAs opened in response to this observation to demonstrate your proposed corrective actions will be effective, nor did it indicate that it will be performing any retrospective review of previous complaints or trends to ensure CAPAs have been opened appropriately and as required by your procedure.

2. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented, as required by 21 CFR 820.30(c).

For example, your firm failed to establish design inputs for the Level 1 and Level 2 Controls used in LeadCare II Blood Lead Testing Systems as required by your Design Control Procedure, SOP 131, Revision 13, Effective Date June 6, 2021. The Instructions for Use for LeadCare II Blood Lead Testing System states that Level 1 and Level 2 controls are intended "to verify system performance and accuracy before testing patient results." Yet, the Design Requirement Matrix, Rev G, dated July 1, 2020, which was provided as the latest specification for LeadCare II testing system, fails to establish specific and separate design requirements for the Level 1 or Level 2 Controls that are part of the LeadCare II testing system.

We reviewed your firm’s responses and concluded they are not adequate. Your firm indicated that a CAPA will be opened to evaluate the level 1 and 2 controls and will also include a retrospective review of complaints to further evaluate the issue. However, your firm did not provide a copy of the CAPA to demonstrate your proposed corrective actions will be effective. Also, your response did not include a timeline for revising your design documents nor any plans for assessing your design control program to mitigate the above observation.

3. Failure to establish and maintain procedures for validating the device design. Design validation shall be performed under (b)(4) operating conditions on (b)(4) production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF, as required by 21 CFR 820.30(g). For example:

A) Your firm did not validate the cleaning and decontamination instructions written in the Instructions for Use (IFU) for Blood Lead Testing Systems - LeadCare II, LeadCare Ultra, and LeadCare Plus Analyzers.

B) Your firm failed to adequately establish your Risk Management Procedure SOP 159, Rev 08, dated March 12, 2025, which requires the Risk Management File to be updated periodically or when previously unrecognized hazards are present. For example:

o Your firm failed to update your risk files for your LeadCare II test system, after becoming aware of an increase in false positive complaints associated with the use of (b)(4) Tubes from October 7, 2024, to August 14, 2025. Specifically, your DFMEA dated December 1, 2022, PFMEA dated November 5, 2020, and UFMEA dated June 18, 2020, were not updated to include this previously unrecognized hazard.

o Your firm failed to update your risk files for their LeadCare II test system, after becoming aware of two separate labeling control failures during manufacturing in March of 2023 and again in May of 2024 that resulted in mislabeled products being distributed. Specifically, the PFMEA dated November 5, 2020, was not updated to identify any risks associated with the mislabeling of products being released.

We reviewed your firm’s responses and concluded they are not adequate. Your firm indicated it will validate the cleaning process and expect this to be completed by January 9, 2026. Your firm’s response noted a CAPA will be opened for review and revision of the risk management files, but did not provide any details, including a copy of the CAPA to demonstrate your proposed corrective actions will be effective. Also, the responses did not include a plan to perform any retrospective review of ECO’s to ensure risk management files will be updated appropriately.

4. Failure to validate a process with a high degree of assurance and approved according to established procedures, when the results of a process cannot be fully verified by subsequent inspection and test. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented, as required by 21 CFR 820.75(a). For example:

A) Your firm failed to have validation data to demonstrate how calibration verification with only (b)(4) of data can ensure reliable device performance across the reportable range for a diagnostic device. Your calibration verification procedure 65055, allows exclusion of up to (b)(4) of test results when they exceed the reportable range. This procedure includes instructions for operators to "leave blank" any "High" results and exclude "obvious outliers or contaminated samples," and if remaining data fails bias specification, it allows (b)(4) calibration adjustments.

B) Your firm failed to validate the revised manufacturing process which included new acceptance criteria to include (b)(4), to demonstrate consistent manufacturing capability. Engineering Change Order (ECO) 7378 was initiated on June 30, 2023, to “Update Procedures for "LC II Sensor Calibration Verification" (Document Reference 650055) and "LeadCare Ultra Sensor Calibration Verification Procedure" (Document Reference 65064) to include release requirements for (b)(4) and (b)(4) based on the (b)(4) testing data obtained.” The ECO noted this process change was considered a low risk, and no additional validation was performed, even though this is critical acceptance criteria.

We reviewed your firm’s responses, and concluded they are not adequate. Your responses indicated CAPAs were opened to address the above items; however, they did not provide a copy of the CAPAs to demonstrate your proposed corrective actions will be effective or a plan to ensure re-validation is performed, as necessary, when manufacturing operations are revised, including anytime acceptance criteria is modified.

5. Failure to establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).

For example, your firm failed to establish adequate incoming inspection procedures for capillary collection tubes used with your blood lead testing kits. The current procedure requires a sample of (b)(4) tubes from lot sizes of (b)(4) units per (b)(4) for packaging verification only. Your Incoming Inspection Procedure, SOP 105, Rev 10, Effective Date April 18, 2025, does not specify inspection of any critical quality attributes for these capillary tubes.

We reviewed your firm’s responses and the adequacy cannot be determined at this time. We understand that you plan to revise specifications for LCII Blood Collection Capillary – Plungers Kit, and plan to initiate incoming inspection on these components, including testing the tubes for lead, however, these revisions are still in progress. We will need to verify that your firm is performing sufficient inspections to ensure these components meet their required specifications.

6. Failure to have written sampling plans that are based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented, as required by 21 CFR 820.250(b).

For example, your firm failed to follow your Statistical Methods & Analysis of Data Procedure, SOP 139, Rev 04, Effective Date November 16, 2020, Section 6.5, which requires adequate sample size justification for process/product verification/validation/test method validation studies. Validation testing performed on August 30, 2023, to validate mold modification of caps through (b)(4) Caps (P/N (b)(4)), inspected only 10 caps from Cavity (b)(4) and Cavity (b)(4) (5 each) without describing lot size or providing valid statistical rationale for the sample size chosen.

We reviewed your firm’s responses and the adequacy cannot be determined at this time. You indicated a CAPA was opened to review your procedures related to statistical evaluation, but you did not provide any additional documentation, including a copy of the CAPA to demonstrate your proposed corrective actions will be effective.

Medical Device Reporting (MDR) Violations

Our inspection also revealed that your firm’s LeadCare Plus Blood Lead Testing Systems are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 ‐ Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to report to us the information required by § 803.52 in accordance with the
requirements of § 803.12(a), no later than 30 calendar days after the day that your firm receives or otherwise become aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example:

• The information included for Complaint #MAG-CC-05942 describes an event where the pediatric patient experienced a false negative result while using your firm’s LeadCare Plus blood lead testing system, as a result of a device malfunction (e.g., corroded sensor pin). We believe this malfunction resulted in the device’s failure to perform its essential function and compromise the device’s diagnostic effectiveness and would be likely to cause or contribute to a death or serious injury. There’s no information included for the complaint indicating that the malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Accordingly, the complaint represents an MDR-reportable malfunction, as defined in 21 CFR 803.3. Your firm became aware of the event on October 30, 2023, and firm failed to submit the MDR within the required 30-calendar-day timeframe.

• The information included for Complaint # MAG-CC-06971, describes a malfunction (i.e., analyzer emitting a burning smell) involving your firm’s LeadCare Plus Blood Lead Testing System. Your firm became aware of MAG-CC-06971 on July 17, 2024, and submitted a malfunction MDR for the event. FDA received the corresponding MDR# 1218996-2025-00006 on January 29, 2025, which is beyond the 30-calendar day timeframe after becoming aware.

The adequacy of your firm’s responses cannot be determined at this time. Your firm has not yet submitted an MDR for complaint #MAG-CC-05942. In addition, the response states that your firm plans to initiate a CAPA to evaluate and optimize the MDR reporting process and conduct a retrospective review to address the issue in accordance with the revised process. However, your firm has not provided documentation or evidence demonstrating that the systemic corrective actions have been fully implemented, including completion of the retrospective review, as these activities are still ongoing.

Corrections and Removals Violations

Our inspection also revealed that your firm’s LeadCare II Blood Lead Test Kits devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

Failure to submit any report required within 10 working days of initiating a correction or removal, as required by 21 CFR 806.10. For example: Magellan Diagnostics, Inc. became aware of labelling error during assembly of LeadCare II Blood Lead Test Kits, halted assembly and conducted a “Stop Shipment.” Your firm sent a customer communication titled “MEDICAL DEVICE FIELD CORRECTION” dated 5/8/2024, to notify customers that (b)(4) of the LeadCare II Testing Kit calibration button was incorrectly labeled as (b)(4), which could result in inaccurate results and patient testing could be delayed. This action meets the definition of a medical device correction or removal initiated to remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA within 10 working days of initiation. As of the date of the close of the inspection, August 26, 2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.

Your firm’s responses adequately satisfy this citation. Magellan Diagnostics, Inc. notified customers of the problem, initiated a medical device removal, and submitted a Report of Correction or Removal to FDA as of October 27, 2025.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your firm’s manufacturing and quality assurance systems relative to the requirements of the device Quality System regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your firm has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:

• Initial certifications by consultant and establishment – July 31, 2026

• Subsequent certifications – July 31, 2027, and July 31, 2028.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Gina Brackett, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 720826” when replying. If you have any questions about the contents of this letter, please contact: Karen Archdeacon, Compliance Officer at karen.archdeacon@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Barbara C. Marsden
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC: Vernon Brown, Director – Quality Assurance and Regulatory Affairs, vernon.brown@meridianbioscience.com