BEUDAMED
    FDA Recall 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.

    Recall: Z-0295-04 · Initiated December 3, 2003

    Recall

    Recall Number
    Z-0295-04
    Event Number
    27874
    Firm
    Polymedco, Inc
    FEI Number
    1000119795
    Product Code
    DCK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 3, 2003
    Posted
    January 6, 2004
    Terminated
    April 20, 2005
    Address
    510 Furnace Dock Road, Cortlandt Manor, NY, 10567-6220

    Description

    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.

    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.

    Action

    By phone on 12/3/03 and by mail on 12/5/03.

    Distribution

    Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.

    Quantity

    165 Kits