Ortho-Clinical Diagnostics, Inc. Recall: enGen Laboratory Automation System, enGen Track S
Ortho-Clinical Diagnostics, Inc. Recall: enGen Laboratory Automation System, enGen Track S is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Ortho-Clinical Diagnostics, Inc.; Product: enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended f
| Recalling firm | Ortho-Clinical Diagnostics, Inc. |
|---|---|
| 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 for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom. |
| Recall initiated | 20201120 |
| Recall number | Z-0800-2021 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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