FDA Device recall Z-1503-2021
Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodi…
- FDA Device
- Class II
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodi… by Clark Laboratories, citing positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1503-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-17 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Clark Laboratories |
| Distribution | US |
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
Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
Identifiers
| code_info | Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1503-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.