BEUDAMED
    FDA Recall Terminated

    Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.

    Recall: Z-1302-04 · Initiated July 14, 2004

    Recall

    Recall Number
    Z-1302-04
    Event Number
    29550
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CKD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2004
    Posted
    July 31, 2004
    Terminated
    October 14, 2004
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.

    Reason

    Coating defect may result is falsely decreased patient and/or control results.

    Action

    Recall letters dated 7/14/04 were sent to each customer asking that use of these lots be stopped immediately. Testing labs were asked to notify the attending physician for any patients tested with these test strips.

    Distribution

    United States.

    Quantity

    166 boxes