FDA Device recall Z-1222-2024
VITROS XT7600 Integrated System
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of VITROS XT7600 Integrated System by Ortho Clinical Diagnostics, citing potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1222-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-22 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS XT7600 Integrated System
Reason
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Identifiers
| code_info | Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1222-2024%22
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