VITROS 250 Chemistry System Refurbished — Class II medical device recall Z-1935-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-07-10, distributed nationwide. Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
| Recall number | Z-1935-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-04-08 |
| Classified | 2019-07-03 |
| Reported by FDA | 2019-07-10 |
| Terminated | 2020-11-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,411 units |
| UPC / GTIN / UDI-DI | 10758750001330 |
Product
VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
Reason for recall
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
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-1935-2019. 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.