Trinity Biotech — Class III medical device recall Z-2445-2012
Terminated recall by Clark Laboratories, Inc. (dba,Trinity Biotech USA), reported 2012-10-03, distributed nationwide. The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out
| Recall number | Z-2445-2012 |
|---|---|
| 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 | 2012-05-29 |
| Classified | 2012-09-24 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2016-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 810 kits |
| Lot numbers | 2325600-566, 2325600-567, 2325600-568, 2325601-566, 2325601-567 |
Product
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Reason for recall
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR 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-2445-2012. 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.