Events

Recall of Device Recall EIA AntidsDNA 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
    56044
  • Event Risk Class
    Class 2
  • Event Number
    Z-1647-2011
  • Event Initiated Date
    2010-03-02
  • Event Date Posted
    2011-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92478
  • 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
    Anti-dna antibody (enzyme-labeled), antigen, control - Product Code LRM
  • Reason
    The firm received customer complaints of increased positivity rates associated with the anti-dsdna test kits.
  • Action
    The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 2, 2010 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and quarantine the affected kit lots; discard all affected product in accordance with all local, state and federal disposal procedures; complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM via fax to: (510) 741-3954, attn: Bio-Rad CSD Regulatory Affairs Department, and to please re-evaluate all positive patient samples and retest if necessary. If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.

Device

Device Recall EIA AntidsDNA Test Kit
  • Model / Serial
    Lot Numbers: 23191977, exp. 10/31/2010 23191979, exp. 10/31/2010 23191990, exp. 10/31/2010 23192172, exp. 10/31/2010 23192174, exp. 10/31/2010 23192175, exp. 12/31/2010 23192176, exp. 12/31/2010 23192490, exp. 2/28/2011 23100007, exp. 2/28/2011 23191837,
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Canada, Carribean, Chile, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Panama, Singapore, South Korea and United Kingdom.
  • Product Description
    Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, || Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA || The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme immunoassay (EIA) intended to screen for the presence of dsDNA antibodies in human serum as an aid in the diagnosis of systemic lupus erythematosus (SLE). For In Vitro Diagnostic Use.
  • 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