Captia Syphilis-G Test Kit Product Usage: This is an enzyme… — Class II medical device recall Z-0572-2014
Terminated recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), reported 2014-01-01, distributed nationwide. Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
| Recall number | Z-0572-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA), Jamestown, NY, United States |
| Recall initiated | 2013-08-27 |
| Classified | 2013-12-26 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2016-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 38 kits |
| Lot numbers | 082 |
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.
Reason for recall
Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0572-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.