Recall Z-0296-04 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Polymedco, Inc
POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). 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 | 584 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 |