VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 — Class II medical device recall Z-0392-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-11-14, distributed nationwide. The reagent pack exhibits the potential for an increased frequency of calibration failures.
| Recall number | Z-0392-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-08-28 |
| Classified | 2018-11-06 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BM, BR, CA, CL, DE, DK, ES, FR, GB, IN, IT, PT |
| Quantity | 6,630 |
| Lot numbers | 2601, 2610, 2620 |
| Model numbers | 1453489 |
Product
VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia
Reason for recall
The reagent pack exhibits the potential for an increased frequency of 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-0392-2019. 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.