FDA Device recall Z-1743-2015
VITROS 5600 Chemistry System, Software Version 3.2 & Below
- FDA Device
- Class II
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class II recall of VITROS 5600 Chemistry System, Software Version 3.2 & Below by Ortho Clinical Diagnostics, citing software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biase….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1743-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-06 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Reason
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
Identifiers
| code_info | Product Code: 6802413 Unique Device Identifier No.: 10758750002740 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1743-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.