Trinity Biotech Captia Measles IgM — Class III medical device recall Z-2782-2016
Terminated recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), reported 2016-09-21, distributed nationwide. The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping
| Recall number | Z-2782-2016 |
|---|---|
| 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 | 2016-07-11 |
| Classified | 2016-09-12 |
| Reported by FDA | 2016-09-21 |
| Terminated | 2017-05-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, HK |
| Reason classes | specification failure |
| Lot numbers | 2326060-043 |
| Expiration dates | 2017-05-31 |
Product
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Reason for recall
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
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-2782-2016. 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.