VITROS Chemistry Products Na+ Slides — Class II medical device recall Z-0992-2019
Terminated recall by Ortho-Clinical Diagnostics, reported 2019-03-20, distributed in AL, CA, CT, FL, HI, IA, ID, IL…. Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control
| Recall number | Z-0992-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2019-01-22 |
| Classified | 2019-03-08 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2022-06-10 |
| Distributed | AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, WY |
| Countries outside the US | CA |
| Quantity | 1,448 |
| Lot numbers | 4221-0998-3223 |
| Model numbers | 8379034 |
Product
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 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
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid 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-0992-2019. 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.