BEUDAMED
    FDA Recall Terminated

    COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy.

    Recall: Z-2586-2011 · Initiated April 14, 2011

    Recall

    Recall Number
    Z-2586-2011
    Event Number
    58784
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    MZP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2011
    Posted
    June 17, 2011
    Terminated
    August 27, 2012
    Address
    1080 US Highway 202, South Somerville, NJ, 08876-3733

    Description

    COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy.

    Reason

    The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.

    Action

    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated April 14, 2011 and faxback form to their customers UPS ground. The letter described the product, problem and actions to be taken. The customers were instructed to review prior test results if there have been indications of discrepancies between test results generated with COBAS AmpliPrep/COBAS TaqMan HCV Test as compared to other relevant clinical and laboratory findings; complete and return the attached Product Advisory Notice: Affiliate Feedback Fax-Form via fax to: 1-866-792-5445, and file this letter for future reference, in particular for use with their 2010 CAP Survey Results to explain any under-quantitation of sample HVL 2-01. Please contact Roche Molecular Diagnostics Technical Support at 1-800-526-1247 if you have any questions about the information contained in this letter.

    Distribution

    USA (nationwide) and 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, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudia Arabia, Sinagpore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.

    Quantity

    50,993 units