BEUDAMED
    FDA Recall Terminated

    COBAS TaqMan 48 Analyzers.

    Recall: Z-1120-04 · Initiated May 24, 2004

    Recall

    Recall Number
    Z-1120-04
    Event Number
    29358
    Firm
    Roche Molecular Systems Inc
    FEI Number
    1000121742
    Product Code
    JJF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 24, 2004
    Posted
    July 27, 2004
    Terminated
    March 8, 2006
    Address
    11 Franklin Ave, Belleville, NJ, 07109-3501

    Description

    COBAS TaqMan 48 Analyzers.

    Reason

    Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.

    Action

    An Urgent Product Recall letter was sent to all customers with a COBAS TaqMan 96 and 48 analyzer on 5/24/2004 by overnight delivery with delivery confirmation. On May 25, 2004, All Roche Field Service Engineers were instructed to inspect the analyzers to confirm that the cables were properly seated.

    Distribution

    Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.

    Quantity

    75