BEUDAMED
    FDA Recall Terminated

    FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix, 1 x 78 uL 2. FIIG20210A R mix, 1 x 78 uL 3. FIIG20210A CT, 1 x 50 uL 5, FIIG20210A DIL 1 x 1 mL Manufactured in Germany Distributed by Roche Diagnostics, Indianapolis, IN

    Recall: Z1006-2010 · Initiated March 12, 2009

    Recall

    Recall Number
    Z1006-2010
    Event Number
    53708
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    NPR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 12, 2009
    Posted
    March 5, 2010
    Terminated
    June 9, 2010
    Address
    1080 Us Highway 202 S, Somerville, NJ, 08876-3733

    Description

    FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix, 1 x 78 uL 2. FIIG20210A R mix, 1 x 78 uL 3. FIIG20210A CT, 1 x 50 uL 5, FIIG20210A DIL 1 x 1 mL Manufactured in Germany Distributed by Roche Diagnostics, Indianapolis, IN

    Reason

    Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. These rare mutations will lead to an unknown result after performing genotyping.

    Action

    Product Advisory Notices were sent via e-mail on 3/12/09 to Roche Local Safety Officers and Roche county General Manager. Local Safety Officers and General Managers were to communicate to the end users with the Important Product Notice. In addition, Reagent Bulletin 09-052, dated 3/27/09, was issued to Roche U.S. Affiliate of U.S. customers.

    Distribution

    Nationwide Distribution

    Quantity

    9624 kits