Trinity Biotech Captia Measles IgM Kit — Class II medical device recall Z-1503-2021
Terminated recall by Clark Laboratories, Inc., reported 2021-05-05, distributed nationwide. Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retes
| Recall number | Z-1503-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clark Laboratories, Inc., Jamestown, NY, United States |
| Recall initiated | 2021-03-17 |
| Classified | 2021-04-27 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2022-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | IE |
| Quantity | 80 kits |
| UPC / GTIN / UDI-DI | 05391516743655 |
| Lot numbers | 2326060-060 |
| Model numbers | 2326060 |
| Expiration dates | 2021-06-28 |
Product
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.
Reason for recall
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
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-1503-2021. 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.