Events

Recall of Device Recall Autoimmune EIA ANA Screening Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories 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
    56385
  • Event Risk Class
    Class 2
  • Event Number
    Z-1479-2011
  • Event Initiated Date
    2010-03-01
  • Event Date Posted
    2011-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93344
  • 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
    Antinuclear Antibody, Antigen Control - Product Code LKJ
  • Reason
    The firm received customer complaints of increased positivity rates associated with the ana screening kit due to a decline in stability.
  • Action
    An Urgent: Medical Device Recall Notification, dated March 1, 2010, was provided to the firm's consignee, identifying the affected product and stating the reason for the recall. The letter also asked the customer to examine their inventory and quarantine the affected kits. If the product had been further distributed, those customers must be identified, notified, and asked to discontinue use of the affected product. Customers were to discard all affected product and complete and return the enclosed Medical Device Recall Response Form. The letter also stated that replacement kits would be available in mid-March.

Device

Device Recall Autoimmune EIA ANA Screening Kit
  • Model / Serial
    Lot Numbers: 24591524, exp 10/31/2010; 24591936, exp 12/31/2010; and 24500022, exp 12/31/2010.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- New York, US.
  • Product Description
    Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, || Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. || Intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases.
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • Manufacturer Address
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA