BEUDAMED
    FDA Recall Terminated

    BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.

    Recall: Z-1505-06 · Initiated August 17, 2006

    Recall

    Recall Number
    Z-1505-06
    Event Number
    35794
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LHJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 17, 2006
    Posted
    September 16, 2006
    Terminated
    March 9, 2007
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.

    Reason

    False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component.

    Action

    The recalling firm notified distributors and end users by e-mail, faxed letters, and certified courier on 08/17/06.

    Distribution

    Worldwide-product was sold to distributors and end users

    Quantity

    1,572 kits