FDA Device recall Z-0992-2019
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only
- FDA Device
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only by Ortho Clinical Diagnostics, citing imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0992-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-22 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, WY |
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
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Identifiers
| code_info | Lot 4221-0998-3223 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2019%22
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