VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 — Class II medical device recall Z-1112-2022
Ongoing recall by Ortho-Clinical Diagnostics, Inc, reported 2022-05-25, distributed nationwide. Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic P
| Recall number | Z-1112-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Inc, Raritan, NJ, United States |
| Recall initiated | 2022-03-25 |
| Classified | 2022-05-18 |
| Reported by FDA | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PT, RU, SE, SG |
| UPC / GTIN / UDI-DI | 10758750000302 |
| Lot numbers | 3100, 3111, 3120, 3130, 3140, 3145, 3150, 3160, 3170, 3180, 3190, 3200, 3210 |
Product
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Reason for recall
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
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-1112-2022. 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.