FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
FDA Device Recall #Z-1798-2018 — Class II — February 13, 2018
Recall Summary
| Recall Number | Z-1798-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 13, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Inpeco S.A. |
| Location | Lugano, N/A |
| Product Type | Devices |
| Quantity | 18 |
Product Description
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Reason for Recall
Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
Distribution Pattern
Distributors in 2 states: NY and IL.
Lot / Code Information
Serial Numbers: Accelerator a3600 - ACP.150 ACP.185 ACP.186 ACP.192 ACP.202 ACP.214 FlexLab - FLX.0165 FLX.0127 FLX.0128 FLX.0133 FLX.0157 FLX.0160 FLX.0181 Aptio Automation - AP2.0054 AP2.0056 AP2.0060 AP2.0078 AP2.0095 Part Numbers of impacted sample tube carriers: 721501001 for 43 mm carriers, and 0A00006957 for 40 mm carriers
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.