FDA Device recall Z-1675-2022
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458 by Ortho Clinical Diagnostics, citing performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1675-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-19 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Reason
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Identifiers
| code_info | UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1675-2022%22
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