FDA Medical Device Recalls (openFDA)
Roche Molecular Systems, Inc.: 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.
- Recall number
- Z-2587-2011
- Recalling firm
- Roche Molecular Systems, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-04-14
- Posted
- 2011-06-17
- Terminated
- 2012-08-27
- 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.
- Root 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
- 288,399 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.
- Lot, serial or model codes
- 03568547190; All lots
- 510(k) numbers
- not on file
- PMA numbers
- ["P060030"]
- Product code
- MZP
- Firm FEI
- 2243471
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28