BEUDAMED
    FDA Recall Terminated

    Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.

    Recall: Z-1550-06 · Initiated September 15, 2006

    Recall

    Recall Number
    Z-1550-06
    Event Number
    36157
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CGN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2006
    Posted
    September 29, 2006
    Terminated
    April 30, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.

    Reason

    Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method.

    Action

    Consignees were informed via letter dated 9/15/06 to perform Folate assays in batch mode and to run controls and liquid flow cleaning upon completion of each batch run. Distributors were requested to notify their customers.

    Distribution

    Nationwide.

    Quantity

    5688 units