FDAFDA · Alimentos y medicamentos·N.º oficial Z-0800-2021
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).
Publicado el 13 de enero de 2021 · Inicio del retiro: 20 de noviembre de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ortho-Clinical Diagnostics, Inc.
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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