FDA Device recall Z-0545-2024
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 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 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 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-0545-2024 |
| 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 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 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: 6802413, UDI-DI: 10758750002740; Product Code: 6802915, UDI-DI: 10758750007110; Serial Numbers: J5600…Product Code: 6802413, UDI-DI: 10758750002740; Product Code: 6802915, UDI-DI: 10758750007110; Serial Numbers: J56000116 J56003330 J56000102 J56001793 J56000317 J56003334 J56000161 J56001826 J56001292 J56003342 J56000246 J56001844 J56001523 J56003356 J56000252 J56001925 J56001629 J56003369 J56000418 J56001929 J56001885 J56003373 J56000425 J56001944 J56001886 J56003377 J56000468 J56001979 J56001910 J56003416 J56000512 J56002028 J56002041 J56003433 J56000533 J56002099 J56002064 J56003477 J56000665 J56002116 J56002159 J56003478 J56000671 J56002218 J56002196 J56003484 J56000680 J56002258 J56002198 J56003496 J56000719 J56002300 J56002199 J56003541 J56000831 J56002410 J56002201 J56003570 J56000836 J56002410 J56002249 J56003578 J56000910 J56002460 J56002301 J56003581 J56000929 j56002615 J56002308 J56003583 J56000972 J56002625 J56002358 J56003632 J56000980 J56002625 J56002461 J56003646 J56000993 J56002637 J56002463 J56003655 J56000994 J56002821 J56002466 J56003668 J56001015 J56002862 J56002 |
|---|
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-0545-2024%22
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