BEUDAMED
    FDA Recall Terminated

    Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).

    Recall: Z-1434-04 · Initiated August 20, 2004

    Recall

    Recall Number
    Z-1434-04
    Event Number
    29893
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CKH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 20, 2004
    Posted
    September 2, 2004
    Terminated
    November 5, 2004
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).

    Reason

    Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.

    Action

    Consignees were mailed recall notices dated 8/20/04 and were instructed to either reduce the initial reagent bottle volume prior to use, or to request replacement product.

    Distribution

    Nationwide.

    Quantity

    728 non-expired kits.