Events

Recall of Device Recall BioRad brand Meridian ANA Screen ELISA Test 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
    56386
  • Event Risk Class
    Class 2
  • Event Number
    Z-0613-2011
  • Event Initiated Date
    2010-02-24
  • Event Date Posted
    2010-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93348
  • 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
    False positive test results caused by decrease in the od values of ana cutoff controls and ana positive controls. the increased positivity rates were associated with the meridian ana screening kit. false positive ana values could result in misdiagnosis or mistreatment .
  • Action
    Bio-Rad issued an Urgent Medical Device Recall NOtification letter dated February 24, 2010 to their distributor, identifying the affected product and actions to be taken. The distributor was instructed to examine inventory and quarantive affected kit lots, and to identify and notify customers with affected lots to discontinue use and discard the product. Replacement kits will be distributed. Customers were asked to complete and return a recall response form. Bio-Rad can be contacted at 510 724-7000 concerning this recall.

Device

Device Recall BioRad brand Meridian ANA Screen ELISA Test Kit
  • Model / Serial
    Lot Numbers:   24591982, 24591999, 24592673, 24592393
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: to Meridian Diagnostics in Ohio.
  • Product Description
    Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, || Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics.
  • 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