Events

Recall of VIDAS

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

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
    26945
  • Event Risk Class
    Class 1
  • Event Number
    Z-1209-03
  • Event Initiated Date
    2003-08-06
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28832
  • 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
    Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) - Product Code LJC
  • Reason
    Product's decrease in sensitivity may result in false negative results.
  • Action
    On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field.

Device

VIDAS
  • Model / Serial
    Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA
  • Product Description
    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use || Product Number: 30101
  • Manufacturer
    bioMerieux

Manufacturer

bioMerieux
  • Manufacturer Address
    bioMerieux, 100 Rodolphe Street, Building 1300, Durham NC 27712
  • Source
    USFDA