Events

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
    Recall
  • Event ID
    25589
  • Event Risk Class
    Class 2
  • Event Number
    Z-0616-03
  • Event Initiated Date
    2003-02-07
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26111
  • 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.

Device

Device Recall Rapid IVD test kit for Chlamydia antigen..
  • Model / Serial
    Catalog No. CHLINT, Lot No. 133354, 133174. Foreign distribution.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, and to France, New Zealand and Spain.
  • Product Description
    Chlamydia OIA. For in vitro diagnostic use.
  • Manufacturer
    Thermo Biostar, Incorporated

Manufacturer

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