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Recall Observatory FDA recall evidence

Device product

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.

Z-2141-2020

April 07, 2020

Class II

Product summary

Firm
Inpeco S.A.
Event
Event 85444
Status
Terminated
Classification
Class II
Quantity
3 systems
Official record key
device-enforcement:Z-2141-2020

Official wording

Reason: 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.

Code information: Serial Numbers: ACP.290 ACP.343 ACP.365

Distribution pattern: US Nationwide including in the states of IL, NY.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    firmware of the Interface Modules and the Automation software. This problem