Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322.
FDA device recall Z-0650-05 · 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
- 1800 kits.
- 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 |
|---|---|---|
| ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P (K952337) | Roche Diagnostic Systems, Inc. | 1996-02-09 |