BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL SYNTHASIL

    MDR report key: 23783049 · Received December 11, 2025

    Report

    Report Number
    1217183-2025-00051
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    March 18, 2025
    Report Date
    December 11, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GFO
    UDI-DI
    08426950078920
    PMA / PMN Number
    K060688
    Removal / Correction Number
    TBD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE CUSTOMER COMPLAINTS HAVE BEEN RECEIVED REPORTING VISIBLE MOLD CONTAMINATION IN SOME VIALS OF HEMOSIL SYNTHASIL LOT NO: N1136730, CAUSING QUALITY CONTROL (QC) MATERIALS TO RECOVER HIGH, OUTSIDE THE LABELED ACCEPTANCE RANGES. BASED ON THE INITIAL INVESTIGATION, THE ISSUE WAS ASSESSED AS PRESENTING NEGLIGIBLE SAFETY RISK, AND THEREFORE NEITHER MDR REPORTING NOR A FIELD ACTION WAS REQUIRED AT THAT TIME. HOWEVER, RECENT TESTING SUGGESTS THAT PATIENT RESULTS MAY BE AFFECTED WHEN CONTAMINATED VIALS ARE USED. BASED ON THE ADDITIONAL INFORMATION AND THE REASSESSED (RESCORED) CLINICAL RISK, A CLASS II FDA-REPORTABLE FIELD ACTION IS BEING INITIATED ON DECEMBER 11, 2025, UNDER INTERNAL ID NO. 2025-008-R, INSTRUCTING CUSTOMERS TO DESTROY ANY REMAINING INVENTORY OF LOT: N1136730. IN ADDITION, THE SIX (6) ASSOCIATED COMPLAINTS ARE EACH BEING FILED AS SEPARATE MDRS USING AN AWARENESS DATE OF DECEMBER 9, 2025 (LAST SIGNATURE ON THE RISK ASSESSMENT). ALL SIX COMPLAINTS INVOLVED QC OUT OF RANGE, WITH NO IMPACT TO REPORTED PATIENT RESULTS. NO MDR FOLLOW-UP REPORTS WILL BE SUBMITTED, AS ANY CORRECTIVE ACTION ACTIVITIES WILL BE TRACKED THROUGH THE ASSOCIATED RECALL. THIS RECALL WILL BE REPORTED TO FDA OII/OMDRHI, NORTHEAST DIVISION, AND TRACKED TO A 100% EFFECTIVENESS CHECK IN THE UNITED STATES.

    Description of Event or Problem · 0

    ON 03/19/2025, INSTRUMENTATION LABORATORY RECEIVED A CUSTOMER COMPLAINT REGARDING APPEARANCE ISSUES WITH VIALS OF HEMOSIL SYNTHASIL LOT: N1136730. CUSTOMER NOTICED CONTAMINATION WHEN THREE LEVELS OF QC RESULTS WERE OUT OF RANGE. UPON INSPECTION, THE CUSTOMER OBSERVED A CLOUD OF WHITE CLUMPS INSIDE THE APTT REAGENT VIAL. THE CUSTOMER THEN INSPECTED ALL REMAINING APTT STOCK AT THEIR FACILITY AND DETERMINED THAT OUT OF 33 BOXES, 9 VIALS WERE CONTAMINATED. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534380 HEMOSIL SYNTHASIL ACTIVATED PARTIAL THROMBOPLASTIN GFO INSTRUMENTATION LABORATORY CO. N1136730 08426950078920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown