FDA Device recall Z-2782-2016
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
- FDA Device
- Class III
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class III recall of Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD by Clark Laboratories Dba Trinity Biotech Usa, citing 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 rang….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2782-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-07-11 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Clark Laboratories Dba Trinity Biotech Usa |
| Distribution | US |
Product
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Reason
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).
Identifiers
| code_info | Lot Number 2326060-043, Expiration Date 31 May 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2782-2016%22
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