FDA Medical Device Recalls (openFDA)
Clark Laboratories, Inc. (dba,Trinity Biotech USA): 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.
- Recall number
- Z-0572-2014
- Recalling firm
- Clark Laboratories, Inc. (dba,Trinity Biotech USA)
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-08-27
- Posted
- 2013-12-26
- Terminated
- 2016-05-24
- Reason
- Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
- Root cause
- Process design
- 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.
- Quantity
- 38 kits
- Distribution
- USA Nationwide Distribution in the state of WA
- Lot, serial or model codes
- Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIP
- Firm FEI
- 1318354
- Firm city
- Jamestown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28