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FDAFDA · Food and drugs·Recall number Z-2141-2020

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.

Published June 3, 2020 · Recall initiated: April 7, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Inpeco S.A.
Distributor
US Nationwide including in the states of IL, NY.
Lot
Serial Numbers: ACP.290 ACP.343 ACP.365
Risk classification
Class II
Area (FDA)
device
Country
Switzerland

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