BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT ANTI-C, 5ML

    MDR report key: 22791321 · Received August 13, 2025

    Report

    Report Number
    9610824-2025-00025
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    August 9, 2023
    Report Date
    August 25, 2025
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMNH
    Product Code
    QHR
    UDI-DI
    07611969950348
    PMA / PMN Number
    125226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME WE FILED OUR INITIAL REPORT FOR THIS COMPLIANT, IT HAD NOT YET BEEN ESTABLISHED THAT THE DONOR IS NEGATIVE FOR ANTI-C ANTIGEN. SINCE WE WERE IN DOUBT IF THIS COMPLAINT MEETS FDA'S REPORTING CRITERIA, WE DECIDED TO FILE A REPORT REGARDING A POTENTIALLY FALSE NEGATIVE ANTIBODY TEST RESULT. A FALSE POSITIVE AB TEST WOULD NOT HAVE TRIGGERED A REPORT. FOR THIS REASON, OUR INITIAL REPORT WAS SUBMITTED FOR THE SERACLONE ANTI-C LOT THAT HAD ALLEGEDLY CAUSED A FALSE NEGATIVE TEST RESULT WHILE THIS FINAL REPORT IS SUBMITED FOR THE LOT THAT HAD CAUSED THE POSITIVE TEST RESULT. THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 0

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT ANTIGEN TESTING RESULTS WITH SERACLONE ANTI-C.THE CUSTOMER REPORTED A FALSE POSITIVE TEST RESULT WITH A BLOOD UNIT FROM A DONOR KNOW AS NEGATIVE FOR ANTI-C ANTIGEN: DONOR UNIT (B)(6), NEGATIVE AND TESTED (B)(6) 2023 WITH A PREVIOUS LOT OF PRODUCTS, 9229030-01 (EXP. 13.10.2023, MANUF. 20.07.2022). DONOR UNIT (B)(6), NEGATIVE AND TESTED (B)(6) 2024 WITH THE PRODUCT LOT REPORTED, 9347050-01 (EXP. 15.02.2025, MANUF. 23.11.2023). DONOR UNIT (B)(6), POSITIVE 2+ REPEATABLE WITH ANOTHER VIAL FROM SAME PRODUCT LOT AND TESTED (B)(6) 2024 WITH THE PRODUCT LOT REPORTED, 9347050-01 (EXP. 15.02.2025, MANUF. 23.11.2023). ACCORDING TO THE LAST VERSION OF IFU, V13 APPLICABLE SINCE 30.08.2021, THE CLONE IS MS24. THE OTHER LOT 9229030-01 PREVIOUSLY USED BY THE CUSTOMER HAS BEEN MANUFACTURED 20.07.2022. THEREFORE, THESE TWO LOTS USED BY THE CUSTOMER CONTAIN THE SAME CLONE MENTIONED IN THE LAST VERSION OF IFU, THERE IS NO CHANGE REGARDING THE CLONE. ACCORDING TO THE ADDITIONAL INFORMATION, THE CUSTOMER CONFIRMED THAT THESE THREE RBC BLOOD UNITS ARE FROM THE SAME DONOR. AND THE QC TESTS ARE NOT PERFORMED WITH BIO-RAD REAGENT. IN VIEW OF THE DATE OF TESTS PERFORMED BY THE CUSTOMER AND THE FACT THAT THE REAGENTS ARE EXPIRED, NO RETENTION TESTS CAN BE PERFORMED. THE ISSUE ENCOUNTERED BY THE CUSTOMER IS MOSTLY SAMPLE RELATED WITH THE RBC BLOOD UNIT (B)(6). IT IS POSSIBLE THAT THERE IS A MISLABELING ON THE RBC DONOR BLOOD UNIT WITH THE NON-EXPECTED POSITIVE RESULT. AT THE TIME WE FILED OUR INITIAL REPORT FOR THIS COMPLIANT, IT HAD NOT YET BEEN ESTABLISHED THAT THE DONOR IS NEGATIVE FOR ANTI-C ANTIGEN. SINCE WE WERE IN DOUBT IF THIS COMPLAINT MEETS FDA'S REPORTING CRITERIA, WE DECIDED TO FILE A REPORT REGARDING A POTENTIALLY FALSE NEGATIVE ANTIBODY TEST RESULT. A FALSE POSITIVE AB TEST WOULD NOT HAVE TRIGGERED A REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT ANTIGEN TESTING RESULTS WITH SERACLONE ANTI-C. IN (B)(6) 2023, THEY TESTED A PATIENT SAMPLE FOR THE C ANTIGEN AND THE TEST RESULT WAS NEGATIVE. THE SAME PATIENT WAS TESTED AGAIN IN (B)(6) 2025 WITH ANOTHER LOT OF SERACLONE ANTI-C AND THE TEST RESULT WAS POSITIVE. THE CUSTOMER STATES THAT THERE WERE NO CHANGES REGARDING THE TEST EQUIPMENT OR PROCEDURES BETWEEN 2023 AND THE TEST IN 2025. SHE ALSO STATES TO HAVE FOLLOWED THE INSTRUCTIONS FOR USE. OUR INVESTIGATION OF THIS COMPLAINT IS STILL ONGOING. THE ORIGINAL PRODUCT THAT HAD CAUSED THE ALLEGEDLY FALSE NEGATIVE REACTION HAS ALREADY EXPIRED IN 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75868 BLOOD GROUPING REAGENT ANTI-C, 5ML SERACLONE ANTI-C (RH2 QHR BIO-RAD MEDICAL DIAGNOSTICS GMNH 9347050-01 07611969950348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SERACLONE ANTI-C, LOT 9229030-01, EXP. 2023/10/13.| SERACLONE ANTI-C, LOT 9347050-01, EXP. 02/15/2025.| SERACLONE ANTI-C, LOT 9347050-01, EXP. 2025/02/15.