FDA Device recall Z-2483-2020
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110 by Ortho Clinical Diagnostics, citing modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2483-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-20 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Reason
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Identifiers
| code_info | Affected Serial Number: 56001535 56001152 56001641 56001437 56000786 56000255 56001235 56001280 56001724 5600…Affected Serial Number: 56001535 56001152 56001641 56001437 56000786 56000255 56001235 56001280 56001724 56001062 56000308 56001347 56001184 56000315 56003277 56001352 56000458 56001570 56000825 56000261 56001182 56000559 56000818 56000747 56001139 56000317 56000513 56000755 56000883 56001334 56001445 56001141 56000756 56000824 56000718 56001021 56000339 56000741 56000727 56001131 56001558 56001530 56001089 56000843 56001264 |
|---|
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-2483-2020%22
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