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Data / Medical devices / Switzerland / Inpeco SA

Inpeco SA: FDA-registered device maker in Novazzano Ticino, Switzerland, 2 510(k) clearances

Inpeco SA is registered with the FDA (registration 3010825766) in Novazzano Ticino, Switzerland. It lists 81 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 31, 2012. 15 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Inpeco SA
FDA registration number
3010825766
Address
Via Torraccia 26, Novazzano Ticino, Switzerland, 6883
Owner or operator
Inpeco SA (10047217)
Roles
Exporter to the US, Specification developer
First device listed
July 22, 2014
Registered through
2026
Brand names listed
ACCELERATOR a3600, Aptio Automation, Aptio Automation System, FlexLab X, FlexLab, Several Models, FlexPath Blox, ProTube, Rotanta 460 robotic and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid Phosphatase, Thymolphthale InmonophosphateCKE2Exporter to the USaccessdata.fda.gov
Acid, Lactic, Enzymatic MethodKHP1Exporter to the USaccessdata.fda.gov
Acid, Uric, Uricase (Oxygen Rate)JHC1Exporter to the USaccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Exporter to the USaccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Exporter to the USaccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Exporter to the US, Specification developeraccessdata.fda.gov
Assay, Glycosylated HemoglobinLCP2Exporter to the USaccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Exporter to the USaccessdata.fda.gov
Bromcresol Purple Dye-Binding, AlbuminCJW2Exporter to the USaccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Specification developeraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Exporter to the USaccessdata.fda.gov
Centrifuge, Blood-Bank For In Vitro Diagnostic UseKSO1Exporter to the USaccessdata.fda.gov
Chromatographic Separation, Cpk IsoenzymesJHT2Exporter to the USaccessdata.fda.gov
Colorimetric Method, Cpk Or IsoenzymesJHY2Exporter to the USaccessdata.fda.gov
Colorimetric Method, LipoproteinsJHM1Exporter to the USaccessdata.fda.gov
Colorimetry, AcetaminophenLDP2Exporter to the USaccessdata.fda.gov
Colorimetry, CholinesteraseDIH1Exporter to the USaccessdata.fda.gov
Colorimetry, SalicylateDKJ2Exporter to the USaccessdata.fda.gov
Complement C3, Antigen, Antiserum, ControlCZW2Exporter to the USaccessdata.fda.gov
Complement C4, Antigen, Antiserum, ControlDBI2Exporter to the USaccessdata.fda.gov
Container, Specimen Mailer And Storage, Non-SterileNNK1Exporter to the USaccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Exporter to the USaccessdata.fda.gov
CyclosporineMKW2Exporter to the USaccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Exporter to the USaccessdata.fda.gov
Dispensers, ParaffinIDW1Specification developeraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Exporter to the US, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Specification developeraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Exporter to the US, Specification developeraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Exporter to the USaccessdata.fda.gov
Enzymatic Method, AmmoniaJIF1Exporter to the USaccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, CarbamazepineKLT2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DigitoxinLFM2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DigoxinKXT2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, DiphenylhydantoinDIP2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, GentamicinLCD2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, LidocaineKLR2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, N-AcetylprocainamideLAN2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUExporter to the USaccessdata.fda.gov
Enzyme Immunoassay, PhenobarbitalDLZ2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, ProcainamideLAR2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, TheophyllineKLS2Exporter to the USaccessdata.fda.gov
Enzyme Immunoassay, Valproic AcidLEG2Exporter to the USaccessdata.fda.gov
Ferrozine (Colorimetric) Iron Binding CapacityJMO1Exporter to the USaccessdata.fda.gov
Flame Photometry, LithiumJIH2Exporter to the USaccessdata.fda.gov
Hexokinase, GlucoseCFR2Exporter to the USaccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Exporter to the USaccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Exporter to the USaccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Exporter to the USaccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Exporter to the USaccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Exporter to the USaccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Exporter to the USaccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Exporter to the USaccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Exporter to the USaccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Exporter to the USaccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Exporter to the USaccessdata.fda.gov
Ph Rate Measurement, Carbon-DioxideJFL2Exporter to the USaccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Exporter to the USaccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Exporter to the USaccessdata.fda.gov
Radioassay, Triiodothyronine UptakeKHQ2Exporter to the USaccessdata.fda.gov
Radioimmunoassay (Two-Site Solid Phase), FerritinJMG2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Free ThyroxineCEC2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Immunoglobulins (G, A, M)CFQ2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, TobramycinKLB2Exporter to the USaccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Exporter to the USaccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Exporter to the USaccessdata.fda.gov
System, Test, Human Chorionic GonadotropinDHA2Exporter to the USaccessdata.fda.gov
System, Test, Low Density, LipoproteinMRR1Exporter to the USaccessdata.fda.gov
Test Reagents For Ethyl AlcoholDMJ2Exporter to the USaccessdata.fda.gov
Test, Natriuretic PeptideNBC2Exporter to the USaccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Exporter to the USaccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 31, 2012K121012FLEXLAB 3.6, ACCELERATOR A3600CEMSubstantially EquivalentInpeco S.P.A.accessdata.fda.gov
January 18, 2005K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULECDTSubstantially EquivalentDade Behring, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 30, 202597887Class IIOngoingFlexLab (FLX); Version: FLX-217-10The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample taccessdata.fda.gov
September 3, 202597565Class IIOngoingFlexLab (FLX) System. Potassium Test System. in vitro diagnosticThe FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.accessdata.fda.gov
November 3, 202393423Class IIOngoingRoche 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 to automate sample prFirmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.accessdata.fda.gov
March 10, 202391950Class IIOngoingInput 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, APT-253-00 ACP-201-00, Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either inappropriate treatment of normal results, or failure to treat abnormal results resulting in abnormal levels. Abnormal potassium levels can resaccessdata.fda.gov
September 10, 202188700Class IIOngoingFlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.accessdata.fda.gov
August 7, 202086263Class IITerminatedFlexLab (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 3.6 Automation is a mFirmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed resultsaccessdata.fda.gov
July 14, 202086581Class IITerminatedFlexLab (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 Post-Analytical processiWhen a Clot Detection Error is generated during the sample aspiration from the Primary Sample Tube the aspirated volume is dispensed into the first empty Secondary Sample Tube. This Secondary Sample Tube is flagged with error 2132 or 1442 and sent to IOM Priority Output Racks to be manually managed. The current error message associated to error 2132 or 1442 accessdata.fda.gov
April 7, 202085537Class IITerminatedFlexLab 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), Rack Output Module ROM4The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.accessdata.fda.gov
April 7, 202085469Class IIOngoingFlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a unified workstation.Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed taccessdata.fda.gov
April 7, 202085454Class IITerminatedInpeco 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-Analytical and Post-When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.accessdata.fda.gov
April 7, 202085444Class IITerminatedFlexLab 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 a modular system deThe identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track aaccessdata.fda.gov
April 7, 202085429Class IIOngoingInpeco 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.elfThe FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.accessdata.fda.gov
August 24, 201881124Class IITerminatedFlexLab (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-Analytical processingThe firm has identified customer sites where there are modules on which the safety pacemaker label is missing. The information regarding the label included in the Operations Manual has been updated to specify that: 1) the risk of a pacemaker malfunction applies to anyone with a pacemaker who may work on these modules; and 2) the minimum safety distance has baccessdata.fda.gov
February 13, 201879645Class IITerminatedFlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation SystemModule 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.accessdata.fda.gov
October 4, 201675513Class IITerminatedFlexLab, 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 Laboratory. The systemInpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets.accessdata.fda.gov

Compare with other makers

Updated November 26, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.