FDA Device recall Z-2358-2023
VITROS Immunodiagnostic Products Troponin I ES Calibrators
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of VITROS Immunodiagnostic Products Troponin I ES Calibrators by Ortho Clinical Diagnostics, citing reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2358-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-05 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products Troponin I ES Calibrators
Reason
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Identifiers
| code_info | Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2358-2023%22
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