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.
This recall has been terminated (originally issued December 26, 2013).
- Recall Initiated
- August 27, 2013
- Posted
- December 26, 2013
- Terminated
- May 24, 2016
- Recall Number
- Z-0572-2014
- Quantity
- 38 kits
- Firm Location
- Jamestown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Distribution
USA Nationwide Distribution in the state of WA
Lot / Code Info
Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
Root Cause
Process design
Action Taken
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.