BEUDAMED
    FDA Recall Terminated

    VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.

    Recall: Z-0316-04 · Initiated October 28, 2003

    Recall

    Recall Number
    Z-0316-04
    Event Number
    27577
    Firm
    Biomerieux, Inc.
    FEI Number
    1039284
    Product Code
    LSR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 28, 2003
    Posted
    July 20, 2004
    Terminated
    August 13, 2004
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle). The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France. The responsible firm on the insert is bioMerieux, Inc., Durham, NC.

    Reason

    Kit may contain incorrect components

    Action

    Recall letters dated 10/28/03 were issued via regular mail instructing the customer to examine the kits to determine whether they contain the CMV IgG SPRS and destroy them if found.

    Distribution

    Distribution was made nationwide to hospitals and laboratories.

    Quantity

    329 kits