BEUDAMED
    FDA Recall Terminated

    Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.

    Recall: Z-0356-2007 · Initiated December 15, 2006

    Recall

    Recall Number
    Z-0356-2007
    Event Number
    36887
    Firm
    Roche Diagnostics Corp.
    FEI Number
    1823260
    Product Code
    CFN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2006
    Posted
    January 17, 2007
    Terminated
    April 23, 2008
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    Description

    Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.

    Reason

    Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers and the R1 reagent of the Tina-quant Hemoglobin A1c assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 800 analyzer.

    Action

    Device correction letters dated 12/15/06 instructing users to perform an extra wash cycle between applications when using both the ALBT2 and IGGT cassettes on the COBAS INTEGRA 700 and 800 analyzers. The recall was extended to via device correction letters dated 2/28/07 instructing users to perform an extra wash cycle between applications when using both the A1C2 and IGGT cassettes on the COBAS INTEGRA 800 analyzer.

    Distribution

    Nationwide.

    Quantity

    18,905