IMMAGE IgM Reagent Part No.: 447610
FDA device recall Z-1150-04 · posted 2004-07-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.
- Root cause
- Other
- Status
- Terminated
- Product code
- DEW
- Quantity affected
- 10,000
- Date initiated
- 2003-06-06
- Date posted
- 2004-07-23
- 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 |
|---|---|---|
| IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (K963868) | Beckman Instruments, Inc. | 1997-02-10 |