Events

Recall of Device Recall PhD System EIA/IFA Software

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
    57778
  • Event Risk Class
    Class 2
  • Event Number
    Z-1726-2011
  • Event Initiated Date
    2011-01-20
  • Event Date Posted
    2011-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97382
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • Reason
    Firm's correction involves advising customers who have implemented a laboratory information system (lis) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. when a patient result fails a validation rule, the qualitative result will indicate "invalid".
  • Action
    The firm, Bio-Rad, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 20, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the PhD Worklist Results to verify that all validations have passed and that the quantitative results are valid; to translate (if necessary) the customer letter, add local contacts information, distribute to all active PhD System customers in their region and provide tracking documentation to CSD-RA for all customers who received the customer letter. If you have any questions, contact the Bio-Rad CSD Regulatory Affairs Department at (510) 741-4618.

Device

Device Recall PhD System EIA/IFA Software
  • Model / Serial
    All versions.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including:Canada, China, Australia, New Zealand, Czech Republic, France, Hong Kong, India, Italy, Korea, Singapore, Sweden, Taiwan and United Kingdom.
  • Product Description
    PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; || The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The network computer provides worklist generation, data management, data reduction and microplate reader control functions. || Product is manufactured by Bio-Rad Laboratories, Inc., Espace European De L Enterprise Strasbourg Schiltigheim, FRANCE
  • Manufacturer
    Bio-Rad Laboratories, Inc.

Manufacturer

Bio-Rad Laboratories, Inc.
  • Manufacturer Address
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA