FDA Device recall Z-1913-2016
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measur…
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measur… by Ortho Clinical Diagnostics, citing ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1913-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-06 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,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
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
Identifiers
| code_info | Software Version 3.2.2 & below; Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979, IVD. |
|---|
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-1913-2016%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.