VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack — Class II medical device recall Z-1765-2017
Terminated recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2017-04-19, distributed in PR. Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568,
| Recall number | Z-1765-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, N/A, United Kingdom |
| Recall initiated | 2017-03-07 |
| Classified | 2017-04-08 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2019-06-14 |
| Distributed | PR |
| Countries outside the US | AU, BM, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, SG, VE |
| Lot numbers | 1570, 1580, 1590 |
| Model numbers | 2156, 680 |
| Expiration dates | 2017-03-22, 2017-04-13, 2017-04-27 |
Product
VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
Reason for recall
Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals for these affected NT-proBNP lots that have been increasing with time since release testing, resulting in higher than expected VITROS Immunodiagnostic Products NT-proBNP level 1 calibrator signals produced, leading to calibration failures.
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-1765-2017. 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.