FDA Device recall Z-0544-2024
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 by Ortho Clinical Diagnostics, citing during planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interfac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0544-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-10 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
Reason
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Identifiers
| code_info | Product Code: 6802445, UDI-DI: 10758750012343; Product Code: 6900440, UDI-DI: 10758750033201; Serial Numbers: J4600…Product Code: 6802445, UDI-DI: 10758750012343; Product Code: 6900440, UDI-DI: 10758750033201; Serial Numbers: J46000208 J46000019 J46000861 J46000209 J46000020 J46000910 J46000240 J46000150 J46000983 J46000497 J46000162 J46001029 J46000864 J46000247 J46001041 J46000865 J46000296 J46001042 J46000898 J46000393 J46001119 J46001030 J46000410 J46001210 J46001064 J46000478 J46001217 J46001125 J46000499 J46001289 J46001132 J46000531 J46001541 J46001252 J46000564 J46001565 J46001293 J46000617 J46001609 J46001462 J46000772 J46001629 J46001703 J46000788 J46001639 J46001704 J46000800 J46001645 J46000820 J46001680 J46000859 |
|---|
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-0544-2024%22
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