VITROS Sodium Slides — Class II medical device recall Z-3280-2018
Terminated recall by Ortho-Clinical Diagnostics, reported 2018-10-10, distributed nationwide. Potential for positively biased results
| Recall number | Z-3280-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2018-05-05 |
| Classified | 2018-09-28 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2021-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BM, BR, CA, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| UPC / GTIN / UDI-DI | 10758750004812 |
| Model numbers | 837, 9034 |
| Expiration dates | 2018-11-01 |
Product
VITROS Sodium Slides, Catalog # 837 9034
Reason for recall
Potential for positively biased results
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-3280-2018. 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.