Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.
FDA device recall Z-0649-05 · posted 2005-03-23 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
- Action taken
- Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 347,000 cassettes
- Distribution
- Nationwide.
- Date initiated
- 2005-02-15
- Date posted
- 2005-03-23
- Date terminated
- 2005-05-17
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C (K003120) | Roche Diagnostics Corp. | 2000-12-18 |