BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT

    MDR report key: 5323393 · Received September 20, 2004

    Report

    Report Number
    1119779-2004-00005
    Event Type
    Other
    Date Received
    September 20, 2004
    Date of Event
    August 26, 2004
    Report Date
    September 17, 2004
    Manufacturer
    GENZYME CORP.
    Product Code
    MHJ
    Removal / Correction Number
    Z-770-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE BD COLORPAC CRYPTOSPORIDIUM/GIARDIA TEST KIT IS AN OEM (ORIGINAL EQUIPMENT MANUFACTURER) FROM (B)(4). BD WAS NOTIFIED IN FEBRUARY / MARCH 2004, THAT (B)(4) HAD IDENTIFIED TWO KIT LOTS THAT SHOULD BE RECALLED: 071093 AND 071138 RESPECTIVELY, DUE TO AN INCREASE IN FALSE POSITIVE CRYPTOSPORIDIUM RESULTS. ONLY THE KIT LOT 071093 WAS DISTRIBUTED BY BD. THIS KIT LOT WAS RECALLED BY BD IN MARCH 2004. THE (B)(4) DISTRICT OFFICE WAS ALSO INFORMED OF THE PRODUCT RECALL. AT THE TIME OF THE RECALL, A VENDOR CORRECTIVE / PREVENTIVE ACTION REPORT ((B)(4)) WAS SENT TO (B)(4) TO ADDRESS THE FALSE POSITIVE CRYPTOSPORIDIUM ISSUE. BD AND (B)(4) AGREED TO A CORRECTIVE ACTION PLAN; FOLLOWING IS A SUMMARY: CONTINUE TESTING KITS ACCORDING TO CURRENT QC RELEASE PROCEDURE, IMPLEMENT SUPPLEMENTAL KIT TESTING OF A PANEL OF AT LEAST 20 OVA & PARASITE NEGATIVE STOLL SPECIMENS, WEEKLY TELECONFERENCES WITH BD TO REVIEW FALSE POSITIVE INVESTIGATION RESULTS AND ACTION ITEM, BD PERFORMED VENDOR AUDIT AT FACILITY, REVISE PRODUCT INSERT TO PROVIDE MORE DIRECT INSTRUCTIONS ON CORRECT TEST INTERPRETATION. A COPY OF THE HEALTH PROFESSIONALS' MEDWATCH FORM HAS BEEN FORWARDED TO THE VENDOR. THE VENDOR HAS SUBMITTED A STATUS REPORT FOR THEIR RECALL, Z-770-4, TO THE (B)(4) DISTRICT OFFICE OF THE US FOOD AND DRUG ADMINISTRATION. THIS REPORT HAS REQUESTED CLOSURE OF THE RECALL BASED ON THE VENDOR CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH FROM HEALTH PROFESSIONAL. MEDWATCH REFERENCED PERFORMANCE ISSUES WITH THE BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT AND THE CUSTOMER'S STUDY FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 BD COLORPAC GIARDIA/CRYPTOSPORIDIUM TEST KIT ANTIGEN TEST KIT MHJ GENZYME CORP. NA 071260

    Patients

    Seq Age Sex Outcome Treatment
    1