Recall – Automated sampling system communication error

Company: Inpeco S.A.
Date of Enforcement Report: 6/10/2020
Class II


FlexLab 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.

Recall Number: Z-2140-2020


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.


Inpeco S.A. on 4/7/2020. Voluntary:  Firm Initiated recall is ongoing.


37 systems


US Nationwide

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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

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