VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in… — Class III medical device recall Z-2225-2023
Ongoing recall by Ortho-Clinical Diagnostics, Inc., reported 2023-08-02, distributed nationwide. May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
| Recall number | Z-2225-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc., Rochester, NY, United States |
| Recall initiated | 2023-05-18 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10758750033324 |
| Lot numbers | 0090 |
| Model numbers | 6192257 |
| Expiration dates | 2023-06-19 |
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 for recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2225-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.