Events

Recall of Device Recall ULTRACRP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Polymedco, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27874
  • Event Risk Class
    Class 3
  • Event Number
    Z-0295-04
  • Event Initiated Date
    2003-12-03
  • Event Date Posted
    2004-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30670
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    C-Reactive Protein, Antigen, Antiserum, And Control - Product Code DCK
  • 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.

Device

Device Recall ULTRACRP
  • Model / Serial
    Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M (EXP. 11/04)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities, physicians, diagnostic laboratories, and distributors located nationwide.
  • Product 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.
  • Manufacturer
    Polymedco, Inc

Manufacturer

Polymedco, Inc
  • Manufacturer Address
    Polymedco, Inc, 510 Furnace Dock Road, Cortlandt Manor NY 10567-6220
  • Source
    USFDA