Events

Recall of IMMAGE IgM Reagent || Part No.: 447610

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    29094
  • Event Risk Class
    Class 3
  • Event Number
    Z-1150-04
  • Event Initiated Date
    2003-06-06
  • Event Date Posted
    2004-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33127
  • 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
    Igg, Antigen, Antiserum, Control - Product Code DEW
  • Reason
    Low level igm serum sample results may be suppressed and an error code generated when using affected lots. error codes are seen as e60 or e66.

Device

IMMAGE IgM Reagent || Part No.: 447610

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA