Recall Z-1107-2007 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Roche Molecular Systems, Inc.
Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
| Date | Aug 2, 2007 (initiated May 21, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 5,806 total |
| Distribution | Nationwide to hospitals and laboratories. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.