FDA Device recall Z-0800-2021
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative…
- FDA Device
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative… by Ortho Clinical Diagnostics, citing A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0800-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-20 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
Reason
A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.
Identifiers
| code_info | enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Sci…enGen Laboratory Automation Systems and VITROS Automation Solutions Using All TCAutomationTM configured with Thermo Scientific Aliquoter & Labeller Module and using Software Versions 4.6 and below |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0800-2021%22
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