BEUDAMED
    FDA Recall Terminated

    Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.

    Recall: Z-0651-05 · Initiated February 15, 2005

    Recall

    Recall Number
    Z-0651-05
    Event Number
    31056
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    LCP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 15, 2005
    Posted
    March 23, 2005
    Terminated
    May 17, 2005
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322.

    Reason

    The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

    Action

    Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.

    Distribution

    Nationwide.

    Quantity

    1800 kits.