Events

Recall of IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. || Part Numbers: || 446360 (250 test kit) || 446260 (50 test kit) || 444970 (10 test kit)

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
    28965
  • Event Risk Class
    Class 3
  • Event Number
    Z-1149-04
  • Event Initiated Date
    2004-01-28
  • 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=32880
  • 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
    Immunoelectrophoretic, Immunoglobulins, (G, A, M) - Product Code CFF
  • Reason
    Inconsistent and incomplete results for igg.

Device

IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Pa...
  • Model / Serial
    M308363 (250 test) M309039 (50 test)  10 test-- M307327, m307329, M307333, M310301, M310302, M310303, M310304, M310305, M305176.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Product Description
    IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. || Part Numbers: || 446360 (250 test kit) || 446260 (50 test kit) || 444970 (10 test kit)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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