Class 2 Device Recall COBAS AmpliPrep / COBAS TaqMan HCV Test, USIVD

• Date Initiated by Firm: April 14, 2011
• Date Posted: June 17, 2011
• Recall Status: Terminated on August 27, 2012
• Recall Number: Z-2586-2011
• Recall Event ID: 58784
• PMA Number: P060030
• Product Classification: Assay,hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c v - Product Code MZP
• Product: 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.
• Code Information: 03568555190; All lots; all expirys
• Recalling Firm/ Manufacturer: Roche Molecular Systems, Inc.; 1080 US Highway 202 South; Somerville NJ 08876-3733
• For Additional Information Contact: Mr. Vincent Stagnitto; 908-253-7569
• Manufacturer 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 50,993 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MZP and Original Applicant = Roche Molecular Systems, Inc.