Events

Recall of Device Recall Kallestad (TM) HEp2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Rad Laboratories.

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
    49083
  • Event Risk Class
    Class 3
  • Event Number
    Z-2428-2008
  • Event Initiated Date
    2008-07-29
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72723
  • 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
    Antimitochondrial Antibody - Product Code DBM
  • Reason
    The homogeneous positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the qc report label included with each test kit.
  • Action
    On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact Technical Support.

Device

Device Recall Kallestad (TM) HEp2
  • Model / Serial
    Lot # and exp: For catalog # 30471: 951567, exp 2/28/09; 954479, exp 12/31/08; 954566, exp 11/30/08; 954895, exp 3/31/09; 955422, exp 2/28/09; 955495, exp 2/28/09; for catalog # 30472: 951564, exp 2/28/09; 954135, exp 2/28/09; 954481, exp 3/31/09; 954567, exp 3/31/09; 954858, exp 3/31/09; 954927, exp 3/31/09; 955197, exp 4/30/09; and for catalog # 32583: 951566, exp 2/28/09.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY.
  • Product Description
    Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.
  • Manufacturer
    Bio-Rad Laboratories

Manufacturer

Bio-Rad Laboratories
  • Manufacturer Address
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA