BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-DS DNA EIA

    MDR report key: 433811 · Received December 16, 2002

    Report

    Report Number
    MW1027007
    Event Type
    Malfunction
    Date Received
    December 16, 2002
    Report Date
    December 16, 2002
    Manufacturer
    BIO-RAD LABORATORIES DIAGNOSTICS GROUP
    Product Code
    KTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROBLEMS STARTED 7/02 AND CONTINUED THROUGH 10/02 LOT 025773 EXP. 5-21-03, LOT 026556 EXP. 7-9-03, LOT 026645 EXP. 9-10-03. ALL LOTS WERE BAD AND EVENTUALLY RECALLED BY VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-DS DNA EIA IN VITRO DIAGNOSTIC TEST FOR ANTI-DS DNA KTL BIO-RAD LABORATORIES DIAGNOSTICS GROUP * 025773
    2 ANTI-DS DNA EIA IN VITRO DIAGNOSTIC TEST FOR ANTI-DS DNA KTL BIO-RAD LABORATORIES, DIAGNOSTICS GROUP * 026557
    3 ANTI-DS DNA EIA IN VITRO DIAGNOSTIC TEST FOR ANTI-DS DNA KTL BIO-RAD LABORATORIES, DIAGNOSTICS GROUP * 026645

    Patients

    Seq Age Sex Outcome Treatment
    1 *