BEUDAMED
    FDA Recall Terminated

    COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD

    Recall: Z-1459-2011 · Initiated December 28, 2010

    Recall

    Recall Number
    Z-1459-2011
    Event Number
    57560
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    MKT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 28, 2010
    Posted
    March 1, 2011
    Terminated
    August 27, 2012
    Address
    1080 Us Highway 202 S, Somerville, NJ, 08876-3733

    Description

    COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD

    Reason

    There is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent Cassette of the COBAS AmpliPrep /COBAS TaqMan HBV v2.0 Test on the COBAS AmpliPrep instrument.

    Action

    Roche sent Urgent Medical Device Correction Letters to their consignees on December 28, 2010 via Fed Ex. The letters advise the customers to verify the correct configuration of the CSI reagent cassette, remind customers to follow the package insert instructions for including all required controls for each batch and advise that review of previously generated results may be warranted. A UMDC Faxback form was attached for the consignee to complete. For questions regarding this recall call 908-253-7569.

    Distribution

    Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom

    Quantity

    93 kits to US; 22,119 kits to foreign