FDA Device recall Z-3280-2018
VITROS Sodium Slides, Catalog # 837 9034
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of VITROS Sodium Slides, Catalog # 837 9034 by Ortho Clinical Diagnostics, citing potential for positively biased results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3280-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-05 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Sodium Slides, Catalog # 837 9034
Reason
Potential for positively biased results
Identifiers
| code_info | UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3280-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.