FDA Device recall Z-2225-2023
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only
- FDA Device
- Class III
- ongoing
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class III recall of VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing may not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2225-2023 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-05-18 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Reason
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Identifiers
| code_info | UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-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-2225-2023%22
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