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Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCA...

FDA Device Recall #Z-2142-2020 — Class II — April 7, 2020

Recall Summary

Recall Number Z-2142-2020
Classification Class II — Moderate risk
Date Initiated April 7, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Inpeco S.A.
Location Lugano, N/A
Product Type Devices
Quantity 70 systems

Product Description

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.

Reason for Recall

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.

Distribution Pattern

US Nationwide including in the states of IL, NY.

Lot / Code Information

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

Other Recalls from Inpeco S.A.

Recall # Classification Product Date
Z-0596-2026 Class II FlexLab (FLX); Version: FLX-217-40; Oct 30, 2025
Z-0595-2026 Class II FlexLab (FLX); Version: FLX-217-10; Oct 30, 2025
Z-0106-2026 Class II FlexLab (FLX) System. Potassium Test System. in... Sep 3, 2025
Z-0107-2026 Class II FlexLab X (FXX) System. Potassium Test System. ... Sep 3, 2025
Z-0560-2024 Class II Roche Cobas 8000 and Cobas PRO Interface Module... Nov 3, 2023

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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