Events

Recall of Device Recall BioRad

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
    31123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0659-05
  • Event Initiated Date
    2005-01-25
  • Event Date Posted
    2005-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37189
  • 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
    Antigen, Galactomannan, Aspergillus Spp. - Product Code NOM
  • Reason
    New instructions to recommend against using samples with visibly high level of blood.
  • Action
    Letters were sent to customers January 25-27, 2005 via overnight mail. Letters advised the customers of the issue and included a new package insert. The firm included a revised package insert to clarify precautions. The firm sent a CORRECTED COPY letter dated January 31, 2005 outlining the changes made in the product insert.

Device

Device Recall BioRad
  • Model / Serial
    Lot # & Expiration dates: 1L044 3/31/03; 2C047 7/31/03; 2H049 9/30/03; 2L050 9/30/03; 2M051 9/30/03; 2M052 11/30/03; 3D053 10/31/04; 3H0055 10/31/04; 3K0054 10/31/04; 4A0056 7/5/2005
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 93 hospitals and medical centers located throughout the US
  • Product Description
    Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.S. by Bio-Rad Laboratories Diagnostics Group 6565 185th Avenue NE, Redmond, WA 98052-5039. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France.
  • Manufacturer
    Bio Rad Laboratories, Inc.

Manufacturer

Bio Rad Laboratories, Inc.
  • Manufacturer Address
    Bio Rad Laboratories, Inc., 6565 185th Ave Ne, Redmond WA 98052-5039
  • Source
    USFDA