FDA Device recall Z-1734-2014
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use
- FDA Device
- Class II
- terminated
- Published 2014-06-18
On 2014-06-18 the FDA classified a Class II recall of VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use by Ortho Clinical Diagnostics, citing potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the V….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1734-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-10 |
| Published | 2014-06-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
Reason
Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected
Identifiers
| code_info | Software Version 3.0 and lower; Serial Numbers J46000108 through J46000403 |
|---|
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-1734-2014%22
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