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
FDA Recall Z-0296-04 · Posted 2004-01-06
Recalling FirmPolymedco, Inc
Recall StatusTerminated
Product CodeDCK
Date Initiated2003-12-03
Date Terminated2005-04-20
Product Quantity584 Kits
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.
Firm Action
By phone on 12/3/03 and by mail on 12/5/03.
Root Cause
Other
Distribution Pattern
Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.