Station, Pipetting And Diluting, For Clinical Use

FDA product code JQW · Class I (low risk) · 21 CFR 862.2750 · Clinical Chemistry

140510(k) clearances
0PMA approvals
23recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K023955BD Viper InstrumentJQW · Traditional Becton, Dickinson & CO06/24/2003SE
K973335Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional Zenyx Scientific , Ltd.04/30/1998SE
K9801802700 Sample ManagerJQW · Traditional Waters Corporation02/12/1998SE
K970420Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional Pharmacia, Inc.06/30/1997SE
K970616Mini Sampler ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.04/21/1997SE
K962687Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional Nichols Institute Diagnostics03/28/1997SE
K962859Mini Sample ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.10/29/1996SE
K961896Microlab 4000, Microlab 4200JQW · Traditional Hamilton Co.08/16/1996SE
K961694ImpactJQW · Traditional Matrix Technologies Corp.06/21/1996SE
K953345GenesisJQW · Traditional Tecan U.S., Inc.11/21/1995SE
K951753Medtec Autoblot 2000JQW · Traditional Medtec, Inc.10/17/1995SE
K952025RobocapJQW · Traditional Pharmacia, Inc.07/26/1995SE
K9445564 Channel DispenserJQW · Traditional Tecan U.S., Inc.10/25/1994SE
K9426554 Channel DispenserJQW · Traditional Tecan U.S., Inc.09/02/1994SE
K942290Star I WorkstationJQW · Traditional Standard Engineering08/26/1994SE
K941498Biomek SL with Biomek SL IncubatorJQW · Traditional Beckman Analytical and Biotechnology Development07/14/1994SE
K941394Stat Fax 2600JQW · Traditional Awareness Technology, Inc.06/03/1994SE
K940390ImpactJQW · Traditional Matrix Technologies Corp.05/03/1994SE
K936258System Washer 100JQW · Traditional Eg&G Berthold04/26/1994SE
K934124Autoquot Automated Aliquotting SystemJQW · Traditional Andronic Devices, Ltd.04/13/1994SE
K933088Plato 3000JQW · Traditional Rosys, Inc.02/25/1994SE
K925547MaxsoftwareJQW · Traditional Diagnostic Products Corp.01/26/1993SE
K923879Assay Software for DPC-MARJ5 Alastat Eia SoftwareJQW · Traditional Diagnostic Products Corp.12/07/1992SE
K922803Wellwash 4 Mark IIJQW · Traditional Denley Instruments, Inc.11/05/1992SE
K922327Denley Wellprep 2 Sample ProcessorJQW · Traditional Denley Instruments, Inc.08/12/1992SE
K922183Wellprep 2000 Sample ProcessorJQW · Traditional Denley Instruments, Inc.08/11/1992SE
K923268Affirm ProcessorJQW · Traditional Microprobe Corp.07/30/1992SE
K921005AutoloaderJQW · Traditional Innovative Medical Systems, Inc.04/29/1992SE
K915492RSP Mega Sample ProcessorJQW · Traditional Tecan U.S., Ltd.02/21/1992SE
K915284Stacking Microplate WasherJQW · Traditional Denley Instruments, Inc.01/22/1992SE
K913809Hy-Prep SystemJQW · Traditional Hyperion, Inc.01/15/1992SE
K913567Wellprep 1JQW · Traditional Denley Instruments, Inc.10/04/1991SE
K913664Rosys Models 100 and 200JQW · Traditional Packard Instrument Co., Inc.08/30/1991SE
K912036Robotic Sample ProcessorJQW · Traditional Tecan U.S., Ltd.07/26/1991SE
K912228Mark 5 Robotic PipettorJQW · Traditional Diagnostic Products Corp.06/06/1991SE
K911712Stratus(R) Automated Sample HandlerJQW · Traditional Baxter Healthcare Corp05/15/1991SE
K910140Electrapette (R)JQW · Traditional Matrix Technologies Corp.02/04/1991SE
K902592Epc Electronic Pipetting SystemJQW · Traditional Ulster Scientific, Inc.07/19/1990SE
K900599Microplate Reagent DispenserJQW · Traditional Denley Instruments, Inc.05/17/1990SE
K896684Kemble Liquid Handling System DispenserJQW · Traditional Schiff & Co.04/16/1990SE
K896631Exec-Wash Solid Phase Washing SystemJQW · Traditional Source Scientific Systems, Inc.04/03/1990SE
K900775Novapath SP Advanced Liquid Handling SystemJQW · Traditional Bio-Rad03/09/1990SE
K897158Abbott Commander Parallel Processing CenterJQW · Traditional Abbott Laboratories03/01/1990SE
K893811Sakura Prep Ai Automatic Liquid Handling SystemJQW · Traditional Sakura Finetek U.S.A., Inc.09/07/1989SE
K894710Dpc-Robostat(Tm)JQW · Traditional Diagnostic Products Corp.08/31/1989SE
K894272Denley Welldill 3JQW · Traditional Denley Instruments, Inc.08/21/1989SE
K894069Abbott Commander Flexible Pipetting CenterJQW · Traditional Abbott Laboratories08/21/1989SE
K894271Denley Wellwash 2 and 4JQW · Traditional Denley Instruments, Inc.08/15/1989SE
K894126Robotic Sample ProcessorJQW · Traditional Tecan U.S., Ltd.08/15/1989SE
K893810Immuno-Wash Automated Tube WasherJQW · Traditional Ocean Scientific, Inc.08/03/1989SE
K893775Du Pont Dimension Psid Clinical Chemistry SystemJQW · Traditional E.I. Dupont DE Nemours & Co., Inc.07/25/1989SE
K893400Serumax (Automated Serum Centrifugation & Station)JQW · Traditional Medical Robotics06/23/1989SE
K893031Delta (TM) Robotic PipettorJQW · Traditional Diagnostic Products Corp.06/21/1989SE
K890578Hi Chem Wash Concentrate Reagent #88805JQW · Traditional Hichem Diagnostics03/10/1989SE
K885340Air Displacement PipetteJQW · Traditional Ulster Scientific, Inc.02/14/1989SE
K883470IDS-1600 Sample Handling SystemJQW · Traditional Baxter Healthcare Corp12/09/1988SE
K883749Probe(Tm) Models 700 and 1000JQW · Traditional Packard Instrument Co., Inc.11/10/1988SE
K881195Dynatech SPD 2000, Number 002-910-0000JQW · Traditional Dynatech Laboratories, Inc.06/07/1988SE
K873416Multi-Access Reagent DispenserJQW · Traditional Electro-Nucleonics Laboratories, Inc.10/09/1987SE
K872363Dynatech SPD 3000, #002-900-0000JQW · Traditional Dynatech Laboratories, Inc.07/16/1987SE
K871687Tytem(R) Reagent DispenserJQW · Traditional Medical Laboratory Automation Systems, Inc.05/20/1987SE
K870544Biomek 1000 Automated Laboratory Work StationJQW · Traditional Beckman Instruments, Inc.04/22/1987SE
K870406Smi DigitronJQW · Traditional American Dade02/25/1987SE
K864875Electra Automatic SamplerJQW · Traditional Medical Laboratory Automation Systems, Inc.02/13/1987SE
K863887Smi Multipettor(Tm)JQW · Traditional American Dade11/05/1986SE
K863624Ultrawash IIJQW · Traditional Dynatech Laboratories, Inc.10/21/1986SE
K863623Ultrawash IJQW · Traditional Dynatech Laboratories, Inc.10/21/1986SE
K862701SurespotJQW · Traditional Helena Laboratories08/19/1986SE
K861580Progroup (TM) Automated Liquid Handling SystemJQW · Traditional Cetus Corp.06/27/1986SE
K861640Modumatic (R) DiluterJQW · Traditional Tri-Continent Scientific, Inc.05/23/1986SE
K860508Posid SamplerJQW · Traditional Organon Teknika Corp.05/02/1986SE
K854406Tecan Robotic Sample Processor(Rsp) #500JQW · Traditional Tecan U.S., Ltd.02/10/1986SE
K852285Dade Blood Gas Ampul InjectorJQW · Traditional American Dade07/09/1985SE
K851403Ventrezyme Allergen Data Reduction SystemJQW · Traditional Ventrex Laboratories, Inc.06/21/1985SE
K850800Dropstirs - Plastic Disposable PipetJQW · Traditional Berwick Medical Products, Inc.04/02/1985SE
K844798Eppendorf DiluterJQW · Traditional Medical Technomics, Ltd.01/07/1985SE
K843779Autoloader IIJQW · Traditional Electro-Nucleonics Laboratories, Inc.01/03/1985SE
K843621Fiax 420 DilutorJQW · Traditional Intl. Diagnostic Technology09/28/1984SE
K843607LabopettorJQW · Traditional Medical Technomics, Ltd.09/21/1984SE
K843606Precision DispenserJQW · Traditional Medical Technomics, Ltd.09/21/1984SE
K842894Kemble 405JQW · Traditional Kemble Instruments, Inc.08/27/1984SE
K843073Fixed Vol. Dispensers, Adjust Vol-HunpipJQW · Traditional Greene International Corp.08/24/1984SE
K842390Syva Iq 190 Digital Pipetter DiluterJQW · Traditional Syva Co.07/25/1984SE
K841043Behring Elisa Processor MJQW · Traditional Behring Diagnostics, Inc.07/06/1984SE
K840938High Speed DispenserJQW · Traditional Micromedic Systems04/19/1984SE
K834590AccuflexJQW · Traditional Micromedic Systems03/19/1984SE
K833959Microlab M Diluter/DispenserJQW · Traditional Syva Co.01/24/1984SE
K833666Ur/Rite SystemJQW · Traditional Wright Laboratories, Inc.01/13/1984SE
K833505Il Model 840 Microprocessor LoaderJQW · Traditional Instrumentation Laboratory CO01/11/1984SE
K832809Accu-Prep Programmable Auto-DiluterJQW · Traditional Beckman Instruments, Inc.10/27/1983SE
K832205Precision Liquid DispenserJQW · Traditional Hamilton Co.08/24/1983SE
K832204Microlab PJQW · Traditional Hamilton Co.08/24/1983SE
K832202PB 600 Repeating DispenserJQW · Traditional Hamilton Co.08/24/1983SE
K831249Pro QuantumJQW · Traditional Abbott Laboratories07/28/1983SE
K831273QST TM Sample ProcessorJQW · Traditional Syva Co.06/02/1983SE
K830319Auto PrepJQW · Traditional Pm America, Inc.03/29/1983SE
K830157Digiflex Automatic PipetteJQW · Traditional Micromedic Systems03/10/1983SE
K823364COUNT-10 System for Stand. UrinalysisJQW · Traditional V-Tech, Inc.12/15/1982SE
K822688Digital Diluter/DispensersJQW · Traditional Hamilton Co.11/05/1982SE
K822208Cavro IQ-190 Sample ProcessorJQW · Traditional Cavro Scientific Instruments, Inc.08/27/1982SE
K821039Uni-Pump 200JQW · Traditional Scientific Mfg. Industries, Inc.05/03/1982SE
K821034Skatron Repeating DispenserJQW · Traditional Skatron, Inc.05/03/1982SE
K821007EclipseJQW · Traditional Scientific Software & Instrument Co.05/03/1982SE
K813426MultiwashJQW · Traditional Flow Laboratories, Inc.12/22/1981SE
K812983DSDJQW · Traditional Pm America, Inc.11/10/1981SE
K812782Dispenser Aspirator Da 300JQW · Traditional Pharmacia, Inc.10/23/1981SE
K812647Emit Auto CarouselJQW · Traditional Syva Co.10/02/1981SE
K811696Il #781, Semi-Automated LoaderJQW · Traditional Instrumentation Laboratory CO07/01/1981SE
K811001Microerma SystemJQW · Traditional Dynatech Corp.05/01/1981SE
K810509Digital Dispensing PumpJQW · Traditional Dynatech Corp.03/06/1981SE
K803092Mic-Bioplate InoculatorJQW · Traditional Pasco Laboratories, Inc.12/22/1980SE
K802520Centrifichem Pipettor Accuracy Calib.JQW · Traditional Union Carbide Corp.11/12/1980SE
K801913Microlab M-Microprocessor Diluter/DispJQW · Traditional Hamilton Co.09/26/1980SE
K801851Centrifichem Pipettor 1000JQW · Traditional Union Carbide Corp.09/16/1980SE
K801271Model 4900 Off-Line Preparation SystemJQW · Traditional Pm America, Inc.06/09/1980SE
K801090J.T. Baker Lsa 290 Pipetter/DiluterJQW · Traditional J.T. Baker Chemical Co.06/09/1980SE
K801030Riause Auto ProcessorJQW · Traditional Electro-Nucleonics Laboratories, Inc.05/28/1980SE
K800606Micromedic Automatic DiluterJQW · Traditional Micromedic Systems04/16/1980SE
K800141Accustroke PipetJQW · Traditional Beckman Instruments, Inc.02/13/1980SE
K800075Micromedic Punch & EluterJQW · Traditional Micromedic Systems02/13/1980SE
K791324Micromedic APS2JQW · Traditional Micromedic Systems08/28/1979SE
K790041Accessory Kit, CentrifichemJQW · Traditional Union Carbide Corp.02/22/1979SE
K782130Mini-Diluter 2JQW · Traditional Dynatech Laboratories, Inc.02/15/1979SE
K781883Diluter, Lsa 290 PipetterJQW · Traditional Kallestad Laboratories, Inc.12/04/1978SE
K781646SRD-2JQW · Traditional Dynatech Laboratories, Inc.10/27/1978SE
K781645Autodiluter 2JQW · Traditional Dynatech Laboratories, Inc.10/27/1978SE
K780912Adjustable DispensorJQW · Traditional Oxford Laboratories, Inc.06/28/1978SE
K780882Diluter/DispenserJQW · Traditional Innovative Medical Systems, Inc.06/28/1978SE
K780785Dilutor TransporterJQW · Traditional Hyland Therapeutic Div., Travenol Laboratories06/14/1978SE
K780789Peralistic Pump Model 2000JQW · Traditional Innovative Medical Systems, Inc.06/13/1978SE
K780208Aspirator, ManuelJQW · Traditional Dade, Baxter Travenol Diagnostics, Inc.03/03/1978SE
K770773Pipette, Diluting, Model ADP-30SDJQW · Traditional G.D. Searle and Co.07/11/1977SE
K770772Pipette, Dispensing, Model ADP-30SDJQW · Traditional G.D. Searle and Co.07/11/1977SE
K770307Micro/Pettor, SmiJQW · Traditional Lederle Laboratories04/05/1977SE
K770355Pipettor W/DetipperJQW · Traditional Sherwood Medical Industries03/08/1977SE
K770193Pipettor, 400, Centrifichem SystemJQW · Traditional Universal Instruments Corp.03/01/1977SE
K770208Motorized Operator for Pipetting Dev.JQW · Traditional Kensington Scientific02/28/1977SE
K761290Compu-Pet 300JQW · Traditional Nuclear Medical Laboratories, Inc.02/24/1977SE
K770210Analytix Auto Sample Prep. Sta. 1600JQW · Traditional G.D. Searle and Co.02/14/1977SE
K770013Pipetting DevicesJQW · Traditional Kensington Scientific01/25/1977SE

Recalls

RecallProductFirmInitiated
Z-1156-2021 Class IIHAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.)…There is a risk that the device can start a fire if flammable liquids contact and enter the device. Hamilton Co01/15/2021Open, Classified
Z-1851-2019 Class IIFreedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as…Gas springs not always replaced within the interval specified. Tecan US, Inc.04/12/2019Terminated
Z-3187-2018 Class IIFreedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or…There is a software issue that can potentially impact sample identification and traceability under specific… Tecan US, Inc.07/23/2018Terminated
Z-0728-2018 Class IIIJANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling…We have become aware through internal testing that JANUS and Janus G3 Automated Workstations were failing… Perkinelmer Life Sciences, Inc.08/02/2017Terminated
Z-2864-2017 Class IITomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample…A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous… Hologic, Inc06/27/2017Terminated
Z-0780-2017 Class IIPerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with…Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips. PerkinElmer, Inc10/13/2016Terminated
Z-0747-2017 Class IIPerkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item…Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate… PerkinElmer, Inc06/24/2016Terminated
Z-0149-2015 Class IIFreedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation…Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of… Tecan US, Inc.09/26/2014Terminated
Z-1560-2013 Class IITecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools…WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are… Tecan US, Inc.02/19/2013Terminated
Z-0056-2013 Class IIAutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate…The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being… Beckman Coulter Inc.04/11/2012Terminated
Z-2013-2012 Class IIAbbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code…In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the… Abbott Molecular01/31/2012Terminated
Z-0002-2013 Class IICOULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a…The recall was initiated because Beckman Coulter has confirmed that the Coulter PrepPlus may experience… Beckman Coulter Inc.01/20/2012Terminated
Z-1726-2011 PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is…Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS)… Bio-Rad Laboratories, Inc.01/20/2011Terminated
Z-1895-2011 Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting…The recall was initiated after erroneous, though potentially credible, results due to intermittent reagent… Beckman Coulter Inc.01/18/2011Terminated
Z-0028-2012 Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and…The recall was initiated because Beckman Coulter has confirmed an issue with the Coulter PrePlus 2. The… Beckman Coulter Inc.08/12/2010Terminated
Z-1759-2010 COULTER PrepPlus 2, Part Number: 378600The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials… Beckman Coulter Inc.01/21/2010Terminated
Z-1758-2010 COULTER PrepPlus, Part Number: 286600The recall was initiated after Beckman Coulter confirmed reports of potential dilution of reagent vials… Beckman Coulter Inc.01/21/2010Terminated
Z-1495-2011 PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the…Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme… Bio-Rad Laboratories Inc09/29/2009Terminated
Z-1620-2011 BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product…To prevent a needle stick while replacing the probe, the firm has initiated a Field Correction, and issued… BD Biosciences, Systems & Reagents01/03/2009Terminated
Z-2233-2008 Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40 Product is…Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity Hamilton Co05/07/2008Terminated
Z-2232-2008 Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is…Manufacturing issue with spring may restrict product to drawing less than 1/2 of its stated measured capacity Hamilton Co05/07/2008Terminated
Z-0454-2009 Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41Incorrect results: under certain circumstances, when transfer volume is not within the set range, the… Beckman Coulter Inc08/30/2007Terminated
Z-1169-2007 Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers…Some product containers may be leaking. Hamilton Co03/29/2007Terminated