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Terminated

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.

FDA Recall Z-0295-04 · Posted 2004-01-06

Recalling FirmPolymedco, Inc
Recall StatusTerminated
Product CodeDCK
Date Initiated2003-12-03
Date Terminated2005-04-20
Product Quantity165 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.

K001009RANDOX C-REACTIVE PROTEINRandox Laboratories, Ltd. · 2000-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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