VITROS Na+ Slides — Class II medical device recall Z-1117-2017
Terminated recall by Ortho-Clinical Diagnostics, reported 2017-02-08, distributed nationwide. There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using V
| Recall number | Z-1117-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2016-12-20 |
| Classified | 2017-01-31 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2018-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, PL, SG, VE |
| UPC / GTIN / UDI-DI | 10758750004812 |
| Expiration dates | 2017-01-01 |
Product
VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Reason for recall
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
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-1117-2017. 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.