Inpeco S.A.
FDA Regulatory Profile
Inpeco S.A. appears in FDA public data with 33 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0595-2026, Class II) was initiated on October 30, 2025. Its most recent 510(k) clearance was granted on August 31, 2012.
Summary
- Total Recalls
- 33
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0595-2026 | Class II | FlexLab (FLX); Version: FLX-217-10; | October 30, 2025 |
| Z-0596-2026 | Class II | FlexLab (FLX); Version: FLX-217-40; | October 30, 2025 |
| Z-0107-2026 | Class II | FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic | September 3, 2025 |
| Z-0106-2026 | Class II | FlexLab (FLX) System. Potassium Test System. in vitro diagnostic | September 3, 2025 |
| Z-0560-2024 | Class II | Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular s | November 3, 2023 |
| Z-1561-2023 | Class II | PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab | March 10, 2023 |
| Z-1563-2023 | Class II | Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: Fl | March 10, 2023 |
| Z-1562-2023 | Class II | Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same prod | March 10, 2023 |
| Z-1559-2023 | Class II | Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: F | March 10, 2023 |
| Z-1560-2023 | Class II | Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: | March 10, 2023 |
| Z-0087-2022 | Class II | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same produ | September 10, 2021 |
| Z-2974-2020 | Class II | Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-2 | August 7, 2020 |
| Z-2973-2020 | Class II | FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and | August 7, 2020 |
| Z-2975-2020 | Class II | Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-2 | August 7, 2020 |
| Z-0433-2021 | Class II | Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab ( | July 14, 2020 |
| Z-0432-2021 | Class II | FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka A | July 14, 2020 |
| Z-0434-2021 | Class II | Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelera | July 14, 2020 |
| Z-2200-2020 | Class II | Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems | April 7, 2020 |
| Z-2115-2020 | Class II | Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270 | April 7, 2020 |
| Z-2198-2020 | Class II | FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate mu | April 7, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 | August 31, 2012 |