Events

Recall of Device Recall BioRad Laboratories

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
    28013
  • Event Risk Class
    Class 2
  • Event Number
    Z-0348-04
  • Event Initiated Date
    2003-11-06
  • Event Date Posted
    2004-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31023
  • 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
    Potential drug and device interaction with piperacillin/tazobactam (zosyn) causing positive test result for galactomannan.
  • Action
    Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.

Device

Device Recall BioRad Laboratories
  • Model / Serial
    Lot number: 3F0001  Exp. 2004-05-15
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The firm distributed to hospitals and diagnostic laboratories nationwide.
  • Product Description
    Platelia Aspergillus EIA
  • 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