Recall Z-0295-04 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Polymedco, Inc
POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
| Date | Jan 6, 2004 (initiated Dec 3, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | By phone on 12/3/03 and by mail on 12/5/03. |
| Quantity | 165 Kits |
| Distribution | Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001009 | RANDOX C-REACTIVE PROTEIN Randox Laboratories, Ltd., Aug 4, 2000 |