FDA Device recall Z-2878-2020
VITROS XT3400 Chemistry System, Product code 6844458
- FDA Device
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of VITROS XT3400 Chemistry System, Product code 6844458 by Ortho Clinical Diagnostics, citing when processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2878-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-20 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS XT3400 Chemistry System, Product code 6844458
Reason
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Identifiers
| code_info | Serial numbers J34500122 J34500231 |
|---|
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-2878-2020%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.