Trinity biotech Captia — Class III medical device recall Z-0819-2015
Terminated recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), reported 2014-12-24, distributed in CA, FL, NY, UT. Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot
| Recall number | Z-0819-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA), Jamestown, NY, United States |
| Recall initiated | 2014-11-17 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2016-05-24 |
| Distributed | CA, FL, NY, UT |
| Countries outside the US | ES, FR |
| Reason classes | labeling, specification failure |
| Lot numbers | 033 |
| Model numbers | 800-935 |
| Expiration dates | 2014-11-30 |
Product
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
Reason for recall
Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
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-0819-2015. 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.