POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For I
FDA device recall Z-0295-04 · posted 2004-01-06 · Terminated
Recall details
- Recalling firm
- Polymedco, Inc
- Reason for recall
- Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
- Action taken
- By phone on 12/3/03 and by mail on 12/5/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- 165 Kits
- Distribution
- Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
- Date initiated
- 2003-12-03
- Date posted
- 2004-01-06
- Date terminated
- 2005-04-20
- Location
- Cortlandt Manor, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RANDOX C-REACTIVE PROTEIN (K001009) | Randox Laboratories, Ltd. | 2000-08-04 |