IMMAGE IGALC Reagent Part Number: 447460
FDA device recall Z-1146-04 · posted 2004-07-23 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
- Root cause
- Other
- Status
- Terminated
- Product code
- CFN
- 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 |
|---|---|---|
| BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB (K993547) | Beckman Coulter, Inc. | 2000-02-01 |