Synchron Systems Hemoglobin A1c (HbA1c) Reagent
FDA device recall Z-1101-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJY
- Date initiated
- 2004-07-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-30
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIGIL LIPID CONTROL (K974452) | Beckman Instruments, Inc. | 1997-12-17 |