BEUDAMED
    FDA Recall Terminated

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    Recall: Z-0145-2008 · Initiated May 2, 2007

    Recall

    Recall Number
    Z-0145-2008
    Event Number
    44958
    Firm
    Gen-Probe Inc
    FEI Number
    2024800
    Product Code
    MDK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 2, 2007
    Posted
    December 19, 2007
    Terminated
    May 3, 2010
    Address
    10210 Genetic Center Dr, San Diego, CA, 92121-4362

    Description

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    Reason

    Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

    Action

    Gen-Probe notified customers by phone on May 2nd and 3rd, 2007; a recall notice letter was faxed to each customer on May 3rd, 2007 and mailed on May 4th, 2007 via certified mail. The letter describes the packaging error and the remote health hazard risk, and provides instructions for users to return all kits of this lot number.

    Distribution

    Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT

    Quantity

    106 kits