BEUDAMED
    FDA Recall Terminated

    On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label

    Recall: Z-1202-03 · Initiated July 18, 2003

    Recall

    Recall Number
    Z-1202-03
    Event Number
    26829
    Firm
    Varian, Inc.
    FEI Number
    2026835
    Product Code
    DML
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2003
    Posted
    September 12, 2003
    Terminated
    May 17, 2004
    Address
    25200 Commercentre Drive, Lake Forest, CA, 92630-8810

    Description

    On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label

    Reason

    Stability in question.

    Action

    Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement.

    Distribution

    Nationwide

    Quantity

    11847 kits (50 units/kit)