BEUDAMED
    FDA Recall Terminated

    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).

    Recall: Z-0188-2013 · Initiated July 31, 2012

    Recall

    Recall Number
    Z-0188-2013
    Event Number
    63310
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OWD
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 31, 2012
    Posted
    November 2, 2012
    Terminated
    September 11, 2013
    Address
    1080 Us Highway 202 S, Branchburg, NJ, 08876-3733

    Description

    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).

    Reason

    It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control

    Action

    Roche sent a Safety Board Notice - Product Bulletin 2012-013 on 31-Jul-2012 to affected customers. The notice identifed the affected product, description of situation and actios to be taken. Customers were instructed to discontinue use, quarantine and discard any remaining kits of the affected product in inventory. Customers were advised to contact their affiliate sales office for replacement. The notice states a new cobas 4800 BRAF V600 Mutation Test lot (R07749) is anticipated to be available on 03-Aug-2012. For questions call +01.908.253.7569.

    Distribution

    Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.

    Quantity

    44 kits