ClearanceBrief
510(k) K121012 ยท CEM Electrode, Ion Specific, Potassium

FLEXLAB 3.6, ACCELERATOR A3600

ApplicantInpeco S.P.A., Segrate, Milan, IT
DecisionSubstantially Equivalent, Aug 31, 2012
ReceivedApr 3, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121012

DateFirm and productCodeLinked 510(k)
Nov 26, 2025Inpeco S.A.
FlexLab (FLX); Version: FLX-217-10;
Open, Classified		 CEMNone listed
Nov 26, 2025Inpeco S.A.
FlexLab (FLX); Version: FLX-217-40;
Open, Classified		 CEMNone listed
Oct 9, 2025Inpeco S.A.
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Open, Classified		 CEMNone listed
Oct 9, 2025Inpeco S.A.
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Open, Classified		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
Sep 10, 2021Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Open, Classified		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 JJENone listed
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		 JJENone listed
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		 JJENone listed
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		 JQPNone listed
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		 JQPNone listed
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		 JQPNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 CEMNone listed
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		 JQPNone listed
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		 JQPNone listed
Feb 13, 2018Inpeco S.A.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System
Terminated		 JQPNone listed
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		 CEMNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.