Recall of Device Recall Rapid IVD test kit for Chlamydia antigen..

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Chlamydia ivd test kits may contain diluted conjugate reagent. use may produce a false negative result with a low positive patient sample.
  • Action
    All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.


  • Model / Serial
    Catalog No. CHLINT, Lot No. 133354, 133174. Foreign distribution.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide, and to France, New Zealand and Spain.
  • Product Description
    Chlamydia OIA. For in vitro diagnostic use.
  • Manufacturer


  • Manufacturer Address
    Thermo Biostar, Incorporated, 331 South 104th Street, Louisville CO 80027
  • Source