Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests
FDA device recall Z-1106-2007 · posted 2007-08-02 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJF
- Quantity affected
- 5,806 total
- Distribution
- Nationwide to hospitals and laboratories.
- Date initiated
- 2007-05-21
- Date posted
- 2007-08-02
- Date terminated
- 2010-02-18
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE COBAS AMPLICOR ANALYZER (K964506) | Roche Molecular Systems, Inc. | 1997-05-21 |