Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
Publicado el 3 de junio de 2020 · Inicio del retiro: 7 de abril 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
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Inpeco S.A.
- Distribuidor
- US Nationwide including in the states of IL, NY.
- Lote
- Serial Numbers: ACP.290 ACP.343 ACP.365
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Switzerland
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