BEUDAMED
    FDA Recall Terminated

    Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.

    Recall: Z-2148-2008 · Initiated April 14, 2008

    Recall

    Recall Number
    Z-2148-2008
    Event Number
    48184
    Firm
    Genzyme Corporation
    FEI Number
    1221955
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 14, 2008
    Posted
    August 22, 2008
    Terminated
    September 16, 2008
    Address
    500 Kendall Street, &, Cambridge, MA, 02139

    Description

    Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.

    Reason

    Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.

    Action

    Genzyme notified accounts by Fed'X on 4/14/08 via an Imprtant Field Correction letter, requesting users to discard kits and follow the "User Update" instructions previously provided to minimize calibration error. Customers are to complere and sign the Confirmation of Notification form and fax it back to the firm regardless if they have any affected product or not. Also, requires that the customer confirms that the REagent OD limits for First and Last H are set at 0.15 for Lipase on the Olympus AU400/400e, AU600, AU640/640e and AU2700/AU5400 Systems.

    Distribution

    Nationwide Distribution

    Quantity

    3,443