FDA Device recall Z-2445-2012
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests
- FDA Device
- Class III
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class III recall of Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests by Clark Laboratories Dba Trinity Biotech Usa, citing the Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2445-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Clark Laboratories Dba Trinity Biotech Usa |
| Distribution | US |
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
The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.
Identifiers
| code_info | Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Clark Laboratories Dba Trinity Biotech Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2445-2012%22
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