BEUDAMED
    FDA Recall Terminated

    Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.

    Recall: Z-0659-05 · Initiated January 25, 2005

    Recall

    Recall Number
    Z-0659-05
    Event Number
    31123
    Firm
    Bio Rad Laboratories, Inc.
    FEI Number
    3008272466
    Product Code
    NOM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 25, 2005
    Posted
    March 29, 2005
    Terminated
    April 21, 2005
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    Description

    Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.

    Reason

    New instructions to recommend against using samples with visibly high level of blood.

    Action

    Letters were sent to customers January 25-27, 2005 via overnight mail. Letters advised the customers of the issue and included a new package insert. The firm included a revised package insert to clarify precautions. The firm sent a CORRECTED COPY letter dated January 31, 2005 outlining the changes made in the product insert.

    Distribution

    Product was distributed to 93 hospitals and medical centers located throughout the US

    Quantity

    1547 kits