BEUDAMED
    FDA Adverse Event Other Summary report: N

    LCX GONORRHEA KIT

    MDR report key: 413811 · Received September 3, 2002

    Report

    Report Number
    1415939-2002-00003
    Event Type
    Other
    Date Received
    September 3, 2002
    Date of Event
    August 26, 2002
    Report Date
    August 30, 2002
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LSL
    Removal / Correction Number
    Z-1214-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABBOTT ISSUED A FIELD ACTION ON MULTIPLE LOTS OF LCX NEISSERIA GONORRHEA ON JULY 17, 2002. THE FDA RECALL COORDINATOR WAS NOTIFIED ON JULY 18, 2002. THE FIELD ACTION WAS ISSUED DUE TO DECREASED SENSITIVITY OF SOME LOTS AT OR NEAR THE LIMIT OF DETECTION (10 COLONY FORMING UNITS). ON AUGUST 26, 2002, ABBOTT RECEIVED A LETTER FROM THE FDA DATED AUGUST 23, 2002, CLASSIFYING THE FIELD ACTION AS A CLASS 1 RECALL. ABBOTT ISSUED ANOTHER CUSTOMER LETTER ON AUGUST 29, 2002. ABBOTT HAS NOT RECEIVED ANY REPORTS FROM CUSTOMERS OF PT RESULTS OR MANAGEMENT RELATED TO THE AFFECTED LOTS OF REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCX GONORRHEA KIT IN VITRO LCR DETECTION OF NEISSERIA GONORRHEA LSL ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other