Events

Recall of Device Recall Captia Syphilis IgG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Clark Laboratories, Inc. (dba,Trinity Biotech USA).

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
    66916
  • Event Risk Class
    Class 2
  • Event Number
    Z-0572-2014
  • Event Initiated Date
    2013-08-27
  • Event Date Posted
    2013-12-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124185
  • 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 immunoabsorption assay, treponema pallidum - Product Code LIP
  • Reason
    Trinity biotech recalled trinity biotech captia syphilis igg kits due to false negative results.
  • Action
    Trinity Biotech issued an Urgent Product Information Request letter to their customer on August 27, 2013. The letter identified the affected product, problem and actions to be taken. The request was to determine if their customer did or did not backfill microtiter-strips during the analytical process. If a customer backfilled, they were advised to return the completed request form. On September 11, 2013 Trinity Biotech issued a notice to their customers advising them to re-evaluate any negative patient results for those who perform backfilling. For questions contact Trinity Biotech Help Desk at 800-325-3424, option 2.

Device

Device Recall Captia Syphilis IgG
  • Model / Serial
    Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the state of WA
  • Product Description
    Captia Syphilis-G Test Kit || Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
  • Manufacturer
    Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Manufacturer

Clark Laboratories, Inc. (dba,Trinity Biotech USA)
  • Manufacturer Address
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
  • Manufacturer Parent Company (2017)
    Trinity Biotech plc
  • Source
    USFDA