FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (ak...
FDA Device Recall #Z-0432-2021 — Class II — July 14, 2020
Recall Summary
| Recall Number | Z-0432-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Inpeco S.A. |
| Location | Lugano |
| Product Type | Devices |
| Quantity | 93 |
Product Description
FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) 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
When a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 recommends that the operator manages these Secondary Sample Tubes according to Laboratory Practice, but it does not clarify that these Secondary Sample Tubes may be diluted with water from the hydraulic circuit of the Aliquoter Module this may lead to reporting of erroneous results if the diluted sample is used for testing.
Distribution Pattern
Global Distribution including: USA and countries of: Algeria, Australia, Azerbaijan, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Egypt, Finland, France, Germany, Indonesia, Israel, Italy, Libano, Mexico, Netherlands, Philippines, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, and United Arab Emirates.
Lot / Code Information
The impacted modules are the Aliquoter Modules (lnpeco Part Number FLX-212) with the firmware versions listed below or higher: - AQMb_3-3-0.H86 - AQMa_3-1-1-8.H86 and AQMb_3-1-1-8.H86 - xAQMb_1-1-0.elf; System Serial Numbers: FLX.008 FLX.0118 FLX.064 FLX.101 FLX.0116 FLX.0125 FLX.080 FLX.0206 FLX.0161 FLX.0152 FLX.012 FLX.0121 FLX.0155 FLX.033 FLX.047 FLX.0127 FLX.0128 FLX.0129 FLX.074 FLX.076 FLX.0113 FLX.0138 FLX.014 FLX.015 FLX.0164 FLX.051 FLX.0106 FLX.0158 FLX.0196 FLX.072 FLX.0107 FLX.0189 FLX.0126 FLX.0165 FLX.0135 FLX.017 FLX.0114 FLX.022 FLX.0119 FLX.0105 FLX.029 FLX.0115 FLX.031 FLX.032 FLX.0141 FLX.037 FLX.020 FLX.039 FLX.043 FLX.102 FLX.046 FLX.0143 FLX.050 FLX.0124 FLX.0131 FLX.056 FLX.060 FLX.0136 FLX.0140 FLX.018 FLX.021 FLX.023 FLX.030 FLX.044 FLX.052 FLX.082 FLX.083 FLX.093 FLX.071 FLX.077 TSH.003 FLX.0146 FLX.027 FLX.038 FLX.075 FLX.0160 FLX.0153 FLX.0154 FLX.0157 FLX.0166 FLX.0167 FLX.0170 FLX.0174 FLX.0179 FLX.0180 FLX.0182 FLX.0194 FLX.0183 FLX.0048 FLX.0049 FLX.0109 FLX.0145 FLX.0148
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
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.