Events

Recall of Device Recall Kallestad Mouse Stomach/Kidney (MSK) 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.

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
    56251
  • Event Risk Class
    Class 3
  • Event Number
    Z-3051-2011
  • Event Initiated Date
    2010-06-30
  • Event Date Posted
    2011-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93068
  • 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, Indirect Immunofluorescent, Antigen - Product Code DHN
  • Reason
    Kallestad mouse stomach/kidney (msk) test kits contained crithidia slides instead of the msk slides.
  • Action
    Bio-Rad Laboratories notified affected customers by phone on 6/30/2010 and followed up with a 2nd call on 7/13/2010. The call informed customers of the problem with the kit and requested they destroy the Crithidia slide packs. Bio-Rad send out replacement slide packs. For information or questions on this recall call Bio-Rad at (425) 498-1709.

Device

Device Recall Kallestad Mouse Stomach/Kidney (MSK) Test Kit
  • Model / Serial
    MSK catalog number: 30443. Lot number: 101941. Slide Pack Lot number: 00100889006.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide distribution including the states of CT, OK; and the country of Puerto Rico.
  • Product Description
    "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE FROZEN" || The test kit contains slides and substrate. || For use as an indirect fluorescent antibody procedure for the detection and semi-quantitation of human autoantibodies.
  • 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