Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accel...
FDA Device Recall #Z-0434-2021 — Class II — July 14, 2020
Recall Summary
| Recall Number | Z-0434-2021 |
| 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 | 104 |
Product Description
Aptio 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: AP2.0005 AP2.0008 AP2.0010 AP2.0014 AP2.0017 AP2.0018 AP2.0022 AP2.0023 AP2.0026 AP2.0027 AP2.0033 AP2.0036 AP2.0039 AP2.0043 AP2.0045 AP2.0056 AP2.0060 AP2.0065 AP2.0069 AP2.0070 AP2.0071 AP2.0076 AP2.0078 AP2.0081 AP2.0087 AP2.0089 AP2.0102 AP2.0104 AP2.0105 AP2.0110 AP2.0111 AP2.0113 AP2.0120 AP2.0127 AP2.0137 AP2.0139 AP2.0146 AP2.0147 AP2.0149 AP2.0151 AP2.0155 AP2.0165 AP2.0170 AP2.0172 AP2.0184 AP2.0189 AP2.0201 AP2.0202 AP2.0203 AP2.0209 AP2.0211 AP2.0213 AP2.0217 AP2.0223 APT.0009 APT.0014 APT.0058 APT.0065 APT.0093 APT.0091 APT.0125 AP2.0225 AP2.0230 AP2.0232 AP2.0233 AP2.0240 AP2.0242 AP2.0253 AP2.0266 AP2.0265 AP2.0268 AP2.0269 AP2.0238 AP2.0248 AP2.0274 AP2.0283 AP2.0289 AP2.0285 AP2.0295 AP2.0296 AP2.0303 AP2.0308 AP2.0332 AP2.0350 AP2.0353 AP2.0352 AP2.0354 AP2.0346 AP2.0361 AP2.0366 AP2.0388 AP2.0393 AP2.0402 AP2.0403 AP2.0404 AP2.0405 AP2.0389 AP2.0390 AP2.0400 AP2.0401 AP2.0421 AP2.0420 AP2.0427 AP2.0412
Other Recalls from Inpeco S.A.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0595-2026 | Class II | FlexLab (FLX); Version: FLX-217-10; | Oct 30, 2025 |
| Z-0596-2026 | Class II | FlexLab (FLX); Version: FLX-217-40; | Oct 30, 2025 |
| Z-0107-2026 | Class II | FlexLab X (FXX) System. Potassium Test System. ... | Sep 3, 2025 |
| Z-0106-2026 | Class II | FlexLab (FLX) System. Potassium Test System. in... | 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.