Recall Z-1107-2007
Roche Molecular Systems, Inc. · initiated May 21, 2007
Product
Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
Codes / lots: Catalog number 03576710190, working substrate SB3-SB
Reason for recall
For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.
FDA-determined cause: Other
Action taken
Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.
Details
- Recall number
- Z-1107-2007
- Initiated
- May 21, 2007
- Posted by FDA
- August 2, 2007
- Terminated
- February 18, 2010
- Product code
- MZP – Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Quantity
- 5,806 total
- Distribution
- Nationwide to hospitals and laboratories.
- Recalling firm
- Roche Molecular Systems, Inc., Somerville, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1106-2007 | Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA TestsFor select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a… | 05/21/2007Terminated |