FDA Device recall Z-1348-2016
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110
- FDA Device
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110 by Ortho Clinical Diagnostics, citing the two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized onl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1348-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
Reason
The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
Identifiers
| code_info | Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1348-2016%22
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