ClearanceBrief
Company ยท IT

Inpeco S.A.

FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2012. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
33recalls (2 in 12 months)
33recalls that name a 510(k)

Product codes

CodeDeviceRecords
CEMElectrode, Ion Specific, Potassium25
JQPCalculator/Data Processing Module, For Clinical Use6
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 31, 2012K121012FLEXLAB 3.6, ACCELERATOR A3600
Inpeco S.P.A., IT
CEM

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 26, 2025Inpeco S.A.
FlexLab (FLX); Version: FLX-217-40;
Open, Classified		 CEMK121012
Nov 26, 2025Inpeco S.A.
FlexLab (FLX); Version: FLX-217-10;
Open, Classified		 CEMK121012
Oct 9, 2025Inpeco S.A.
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Open, Classified		 CEMK121012
Oct 9, 2025Inpeco S.A.
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Open, Classified		 CEMK121012
Dec 15, 2023Inpeco S.A.
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order t
Open, Classified		 CEMK121012
May 4, 2023Inpeco S.A.
Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20
Open, Classified		 CEMK121012
May 4, 2023Inpeco S.A.
Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
Open, Classified		 CEMK121012
May 4, 2023Inpeco S.A.
PVT Interface Module (PVT)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: 72747000.A
Open, Classified		 CEMK121012
May 4, 2023Inpeco S.A.
Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: ACP-207-00, ACP-207-01,
Open, Classified		 CEMK121012
May 4, 2023Inpeco S.A.
Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-201-00, APT-201-00,
Open, Classified		 CEMK121012
Sep 10, 2021Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Open, Classified		 CEMK121012
Aug 7, 2020Inpeco S.A.
Aptio Automation systems with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage:
Terminated		 CEMK121012
Aug 7, 2020Inpeco S.A.
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage:
Terminated		 CEMK121012
Aug 7, 2020Inpeco S.A.
FlexLab (FLX) with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Laboratory Automation system - Product Usage: The FlexLab
Terminated		 CEMK121012
Jul 14, 2020Inpeco S.A.
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-Analy
Terminated		 CEMK121012
Jul 14, 2020Inpeco S.A.
Accelerator a3600 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 an
Terminated		 CEMK121012
Jul 14, 2020Inpeco S.A.
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 Pos
Terminated		 CEMK121012
Apr 7, 2020Inpeco S.A.
Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX
Terminated		 JQPK121012
Apr 7, 2020Inpeco S.A.
FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rac
Terminated		 CEMK121012
Apr 7, 2020Inpeco S.A.
Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
Open, Classified		 CEMK121012
Apr 7, 2020Inpeco S.A.
Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instruments into a unified workstation.
Open, Classified		 CEMK121012
Apr 7, 2020Inpeco S.A.
FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.
Open, Classified		 CEMK121012
Apr 7, 2020Inpeco S.A.
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-An
Terminated		 CEMK121012
Apr 7, 2020Inpeco S.A.
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-
Terminated		 CEMK121012
Apr 7, 2020Inpeco S.A.
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - P
Terminated		 JQPK121012
Apr 7, 2020Inpeco S.A.
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX
Terminated		 JQPK121012
Apr 7, 2020Inpeco S.A.
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is
Terminated		 JQPK121012
Apr 7, 2020Inpeco S.A.
Siemens Aptio Automation Centrifuge Module, tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Open, Classified		 JJEK121012
Apr 7, 2020Inpeco S.A.
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Open, Classified		 JJEK121012
Apr 7, 2020Inpeco S.A.
Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
Open, Classified		 JJEK121012
Aug 24, 2018Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analyt
Terminated		 JQPK121012
Feb 13, 2018Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Terminated		 JQPK121012
Oct 4, 2016Inpeco S.A.
FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the La
Terminated		 CEMK121012
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