Inpeco S.A.: Aptio 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) - 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-2142-2020

Recalling firm

Inpeco S.A.

Product

Aptio 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) - 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

2024-02-06

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.

Root cause

Software design

Action

Urgent: Medical Device Correction notification letters dated 3/30/20 were sent to customers. 1) Visually check that the secondary lane of the Interface Modules listed in Table 1 is empty before sending the Off-line command; or 2) Select the "Going to Off-line" command for the Interface Modules listed in Table 1. This ensures that the Module completes processing samples already inside the Module, releases the tubes and then passes to Off-line status. Your service provider will contact you to schedule the firmware upgrade. 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: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224

Quantity

70 systems

Distribution

US Nationwide including in the states of IL, NY.

Lot, serial or model codes

Serial Numbers: AP2.0003 AP2.0007 AP2.0008 AP2.0009 AP2.0010 AP2.0017 AP2.0022 AP2.0025 AP2.0036 AP2.0049 AP2.0052 AP2.0057 AP2.0058 AP2.0059 AP2.0064 AP2.0065 AP2.0077 AP2.0082 AP2.0083 AP2.0089 AP2.0090 AP2.0092 AP2.0098 AP2.0100 AP2.0105 AP2.0109 AP2.0110 AP2.0129 AP2.0136 AP2.0149 AP2.0156 AP2.0173 AP2.0179 AP2.0180 AP2.0181 AP2.0193 AP2.0194 AP2.0201 AP2.0202 AP2.0211 AP2.0230 AP2.0233 AP2.0235 AP2.0236 AP2.0238 AP2.0251 AP2.0254 AP2.0258 AP2.0264 AP2.0269 AP2.0270 AP2.0275 AP2.0289 AP2.0295 AP2.0317 AP2.0325 AP2.0332 AP2.0339 AP2.0375 AP2.0381 AP2.0394 AP2.0411 AP2.0427 APT.0009 APT.0014 APT.0058 APT.0065 APT.0091 APT.0136 APT.0247

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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