FDA Device recall Z-1225-2024
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) by Ortho Clinical Diagnostics, citing A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1225-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-26 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
Reason
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Identifiers
| code_info | VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US…VITROS System Software Version 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201 Serial Numbers US: J46000240 J46000898 J46001030 J46001293 OUS: J46000150 J46001041 J46000190 J46001042 J46000499 J46001186 J46000564 J46001187 J46000801 J46001210 J46000821 J46001217 J46000910 J46001289 J46000933 J46001639 J46001029 J46001645 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Ortho Clinical Diagnostics
- Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products LAC Slides
FDA Device · Class II · 2025-09-24 · Ortho Clinical Diagnostics - VITROS Chemistry Products Ca Slides
FDA Device · Class II · 2025-08-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products CHE Slides
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics - Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Softwar…
FDA Device · Class II · 2025-07-23 · Ortho Clinical Diagnostics
All Ortho Clinical Diagnostics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1225-2024%22
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