Inpeco S.A.: Accelerator a3600 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.

Recall number

Z-2115-2020

Recalling firm

Inpeco S.A.

Product

Accelerator a3600 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.

Status

Terminated

Initiated

2020-04-07

Posted

not on file

Terminated

2024-06-13

Reason

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.

Root cause

Component design/selection

Action

Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. Action to be taken by the user After module protection removal, wait at least 2 seconds before accessing the impacted module (listed in Table 1). Your service provider will contact you to replace the sensor. Until the service visit please maintain awareness on this notice. Please complete and return the "Customer Letter Receipt Confirmation and Implementation Check form" attached to this letter within 15 days directly to the email address specified in the email communication. Please transfer this notice to whom it might concern. Contact reference person: For any clarification you may need, do not hesitate to contact: Eva Balzarotti - Regulatory Affairs Manager E-mail: Regulatorv.Affairs@inpeco.com Phone: (+41) 919118 224

Quantity

2 systems

Distribution

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

Lot, serial or model codes

Serial Numbers: ACP.050 ACP.146

510(k) numbers

["K121012"]

PMA numbers

not on file

Product code

JQP

Firm FEI

3010825766

Firm city

Lugano

Firm state

not on file

Firm country

Switzerland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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