BEUDAMED
    FDA Adverse Event Other Summary report: N

    HIV TEST KIT

    MDR report key: 3598722 · Received January 3, 2014

    Report

    Report Number
    3003871407-2013-00001
    Event Type
    Other
    Date Received
    January 3, 2014
    Manufacturer
    BIOLYTICAL LABORATORIES INC.
    Product Code
    MZF
    PMA / PMN Number
    090032/0
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADVISORY NOTICE SENT OUT ON (B)(4) 2013 TO ALL CUSTOMERS WHO REC'D INSTI HIV-1 ANTIBODY TEST KITS FROM PRODUCTION LOTS B3M172 AND B3M177. CUSTOMERS WERE ADVISED THAT THERE IS A POSSIBILITY THAT A HIGHER THAN EXPECTED NUMBER OF TEST RESULTS MAY BE INTERPRETED AS VERY WEAKLY REACTIVE DUE TO THE POTENTIAL FOR "SHADOWING" ATTRIBUTED TO A SUPPLIER COMPONENT (ABSORBENT PAD IN THE BLOTTED MEMBRANE UNIT) WHEN THE RESULT SHOULD BE NON REACTIVE. CUSTOMERS WERE FURTHER ADVISED THAT CONFIRMATORY TESTING SHOULD BE CONDUCTED FOR ALL REACTIVE RESULTS AS INSTRUCTED IN THE PACKAGE INSERT. CUSTOMERS WERE FURTHER ADVISED THAT A NON REACTIVE RESULT WITH INSTI KITS FROM THESE LOT NUMBERS IS A VALID RESULT. CUSTOMERS WERE FURTHER ADVISED TO CONTACT BIOLYTICAL'S CHIEF TECHNICAL OFFICER IF A HIGHER THAN EXPECTED NUMBER OF FALSE WEAKLY REACTIVE RESULTS ARE OBSERVED. THERE HAVE BEEN NO REPORTS TO THE MANUFACTURER OF ANY PERFORMANCE PROBLEMS WITH THESE TWO INSTI LOTS. BOTH LOTS WERE APPROVED AND RELEASED FOLLOWING BIOLYTICAL'S QUALITY SYSTEM PRACTICES. THIS WAS A PRECAUTIONARY ADVISORY NOTICE BASED ON A QUALITY CONTROL FAILURE OF A SUBSEQUENT, UNRELEASED LOT OF INSTI THAT SHARED THE SAME ABSORBENT PAD LOT. (B)(4).

    Description of Event or Problem · 1

    NO ADVERSE EVENT OR PRODUCT PROBLEM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4675 HIV TEST KIT INSTI 24 TEST KIT WITH SUPPORT MATERIALS MZF BIOLYTICAL LABORATORIES INC. 90-1018 B3M172

    Patients

    Seq Age Sex Outcome Treatment
    1