FDA Device recall Z-1650-2013
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qual…
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qual… by Ortho Clinical Diagnostics, citing there is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1650-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-06 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Reason
There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
Identifiers
| code_info | Serial numbers: J36000111 and J36000520 through J36000617 |
|---|
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-1650-2013%22
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