Inpeco S.A.

FDA Regulatory Profile

Summary

Total Recalls
33
510(k) Clearances
1
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0595-2026Class IIFlexLab (FLX); Version: FLX-217-10;October 30, 2025
Z-0596-2026Class IIFlexLab (FLX); Version: FLX-217-40;October 30, 2025
Z-0106-2026Class IIFlexLab (FLX) System. Potassium Test System. in vitro diagnosticSeptember 3, 2025
Z-0107-2026Class IIFlexLab X (FXX) System. Potassium Test System. in vitro diagnosticSeptember 3, 2025
Z-0560-2024Class IIRoche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular sNovember 3, 2023
Z-1562-2023Class IIVesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same prodMarch 10, 2023
Z-1561-2023Class IIPVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab March 10, 2023
Z-1560-2023Class IIStorage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: March 10, 2023
Z-1563-2023Class IIAlinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlMarch 10, 2023
Z-1559-2023Class IIInput Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FMarch 10, 2023
Z-0087-2022Class IIFlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same produSeptember 10, 2021
Z-2974-2020Class IIAccelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-2August 7, 2020
Z-2975-2020Class IIAptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-2August 7, 2020
Z-2973-2020Class IIFlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and August 7, 2020
Z-0433-2021Class IIAccelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (July 14, 2020
Z-0434-2021Class IIAptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka AcceleraJuly 14, 2020
Z-0432-2021Class IIFlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka AJuly 14, 2020
Z-2142-2020Class IIAptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1April 7, 2020
Z-2198-2020Class IIFlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate muApril 7, 2020
Z-1888-2020Class IIAbbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with FirmApril 7, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K121012FLEXLAB 3.6, ACCELERATOR A3600August 31, 2012