VITROS Chemistry Product Performance Verifier I — Class II medical device recall Z-2366-2020
Terminated recall by Ortho-Clinical Diagnostics, reported 2020-06-24, distributed nationwide. Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when comp
| Recall number | Z-2366-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2020-05-11 |
| Classified | 2020-06-15 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2021-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 10758750004577 |
Product
VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Reason for recall
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
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-2366-2020. 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.