VITROS Chemistry Products GLU Slides-Product Code:1707801 — Class II medical device recall Z-2202-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-08-14, distributed nationwide. Potentially Biased Results using VITROS Chemistry Products GLU Slides
| Recall number | Z-2202-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-06-17 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-11-09 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 10758750009572 |
| Lot numbers | 0048-0964-9287 |
| Expiration dates | 2020-11-01 |
Product
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
Reason for recall
Potentially Biased Results using VITROS Chemistry Products GLU Slides
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-2202-2019. 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.