Inpeco S.A.: Medical Device Recall in 2020 - (Recall #: Z-2114-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 7, 2020

Date Posted: June 3, 2020

Recall Number: Z-2114-2020

Event ID: 85537

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10 systems

Code Information:

Serial Numbers: FLX.0133 FLX.0191 FLX.0192 FLX.0197 FLX.0198 FLX.0201 FLX.0202 FLX.027 FLX.0200 FLX.0181

Distribution Pattern:

The products were distributed to the following US States: IL and NY.

Voluntary or Mandated:

Voluntary: Firm initiated