medical Class II Updated 2020-06-03

Inpeco S.A. recalls FlexLab Automation System used with the following Modules: H

Recalled Product

FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: 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.


Hazard / Issue

The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.

Issued by

FDA

Affected States: IL, NY
Lot/Code Info: Serial Numbers: FLX.0133 FLX.0191 FLX.0192 FLX.0197 FLX.0198 FLX.0201 FLX.0202 FLX.027 FLX.0200 FLX.0181
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