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Terminated

COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human plasma or serum 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. The Test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV.

FDA Recall Z-2587-2011 · Posted 2011-06-17

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeMZP
Date Initiated2011-04-14
Date Terminated2012-08-27
Product Quantity288,399 units

Reason for Recall

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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