FDA Device recall Z-2182-2019
VITROS 4600 Chemistry System, clinical chemistry analyzer
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of VITROS 4600 Chemistry System, clinical chemistry analyzer by Ortho Clinical Diagnostics, citing potential Unsuccessful Calibration Due to Software Anomaly in VITROS System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2182-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-08 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 4600 Chemistry System, clinical chemistry analyzer
Reason
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Identifiers
| code_info | product code: 6900440 UDI: 10758750033201 Affected software : Version 3.3.2 or above |
|---|
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-2182-2019%22
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