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    MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHO·June 23, 2020

    microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059

    FDA Recall
    Completed ·Product code LHO·February 8, 2024

    ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·May 30, 2018

    Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250

    FDA Recall
    Terminated ·Elan Diagnostics, Inc.·Product code CHH·November 7, 2002

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test iQM Part Number:00027415010 300 test iQM Part Number: 00027430010 450 test iQM Part Number: 00027445010 600 test iQM Part number: 00027360010 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test iQM Part Number:00027407511 150 test iQM Part Number: 00027415011 300 test iQM Part Number: 00027430011 450 test iQM Part Number: 00027445011 600 test iQM part Number: 00027360011 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters.

    FDA Recall
    Terminated ·Instrumentation Laboratory Co.·Product code CEM·May 31, 2011

    Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ80438; 6) DONOR FREE FLAP PACK-LF, Pack Number DYNJ0426069N; 7) ENT PACK, Pack Number DYNJ50915B; 8) GENERAL LAPAROSCOPY PACK, Pack Number DYNJ63363G; 9) GENERAL LAPAROSCOPY PACK-LF, Pack Number DYNJ0415393J; 10) GENERAL LAPAROSCOPY PLUS, Pack Number DYNJ66729; 11) GERMANTOWN GENERAL LAP CHO, Pack Number DYNJ60998; 12) KOS LAPAROSCOPY PACK-LF, Pack Number DYNJ51663B; 13) LAP CHOLE, Pack Number DYNJ59943C; 14) LAP CHOLE, Pack Number DYNJ904625D; 15) LAP CHOLE, Pack Number DYNJ902780D; 16) LAP CHOLE I-LF, Pack Number DYNJ83414; 17) LAP CHOLE PACK, Pack Number DYNJ51502A; 18) LAP CHOLE PACK, Pack Number DYNJ16657G; 19) LAP CHOLE PACK, Pack Number DYNJ37370B; 20) LAP CHOLE PACK, Pack Number DYNJ26209N; 21) LAP CHOLE PACK, Pack Number DYNJ04581P; 22) LAP CHOLE PACK, Pack Number DYNJ67745A; 23) LAP CHOLE PACK-LF, Pack Number DYNJ09820J; 24) LAP CHOLE TRAY-LF, Pack Number DYNJ48884C; 25) LAPAROSCOPIC, Pack Number DYNJ57709B; 26) LAPAROSCOPIC COLORECTAL PACK, Pack Number DYNJ80172B; 27) LAPAROSCOPIC PACK, Pack Number DYNJ46550F; 28) LAPAROSCOPIC PACK, Pack Number DYNJ63472; 29) LAPAROSCOPY ESC, Pack Number DYNJ902455I; 30) LAPAROSCOPY PACK, Pack Number DYNJ61652; 31) LAPAROSCOPY PACK, Pack Number DYNJHS0235C; 32) LAPAROSCOPY PACK, Pack Number DYNJ21605J; 33) LAPAROTOMY PACK, Pack Number DYNJ52642F; 34) LAPAROTOMY PACK, Pack Number DYNJ59313B; 35) LEX CYSTO-TUR, Pack Number DYNJ902039F; 36) LUKENS MAJOR PACK, Pack Number DYNJ83049; 37) MAIN & ODS CYSTO PACK, Pack Number DYNJ66821A; 38) MAJOR BASIN PACK, Pack Number DYNJ16629D; 39) MAJOR LAPAROTOMY PACK, Pack Number DYNJ67695A; 40) MAJOR SINGLE BASIN W/GOWNS, Pack Number DYNJS3032; 41) MINOR ABDOMINAL, Pack Number DYNJ44675K; 42) MINOR PACK, Pack Number DYNJ46190G; 43) MINOR PACK, Pack Number DYNJ68885A; 44) MINOR PACK, Pack Number DYNJ45578B; 45) MINOR PACK, Pack Number DYNJ43784A; 46) MINOR PACK-LF, Pack Number DYNJ04690Y; 47) MINOR PROCEDURE PACK, Pack Number DYNJQ0629F; 48) MINOR PROCEDURE PACK, Pack Number DYNJ69256; 49) MINOR UROLOGY PACK, Pack Number DYNJ49310F; 50) MLD PACK, Pack Number DYNJ19521P; 51) MP LAP CHOLE, Pack Number DYNJ49947G; 52) NHCH GENERAL PACK, Pack Number DYNJ51573C; 53) NHCH LAPAROSCOPY PACK, Pack Number DYNJ51575B; 54) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 55) ONCOLOGY MINOR PACK, Pack Number DYNJ52087J; 56) PED LAPAROTOMY PACK, Pack Number DYNJ55538B; 57) PK, URO-CYSTO, Pack Number DYNJ44022B; 58) RF LAP CHOLEPACK (LCLUI)642-LF, Pack Number DYNJ47704G; 59) ROBOT PROSTATECTOMY PACK, Pack Number DYNJ82688; 60) ROBOTIC PACK, Pack Number DYNJ82436A; 61) ROBOTICS PACK, Pack Number DYNJ83622; 62) RR-LAP NEPHRECTOMY PACK-LF, Pack Number DYNJ0785763L; 63) SC LAPAROSCOPY, Pack Number DYNJ49994I; 64) SCRIPPS HEALTH LAPAROSCOPY PK, Pack Number DYNJ66233A; 65) SMALL PROCEDURE PACK, Pack Number DYNJ55378C; 66) TUR / CYSTO PACK, Pack Number DYNJ69574A; 67) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 68) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J; 69) CLOSUREFAST PROCEDURE PACK-LF, Pack Number DYNJ0365463J

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·February 11, 2025

    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 9, 2012

    Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity measurements, the Infinite M1000 PRO can also perform fluorescence polarization and luminescence measurements (including luminescence scans) as well as Amplified Luminescent Proximity Homogeneous Assays (AlphaScreen and AlphaLISA). The Infinite M1000 PRO is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 PRO is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code KHO·May 29, 2015

    VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·February 20, 2019

    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·September 29, 2005

    VITROS ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KHO·August 24, 2011

    AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.

    FDA Recall
    Terminated ·Tosoh Smd Inc·Product code KHO·May 15, 2013

    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code KHO·May 29, 2015

    Tosoh AIA-900 immunoassay Analyzer

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·September 28, 2018

    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 5, 2017

    Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code KHO·January 5, 2017

    TosohSorter 9tray, Product Code 022931and TosohSorter 19tray, Product Code 022932. Product Usage: The AIA-900 9tray Sorter and AIA-900 19tray Sorter supports the automation of the AIA-900 systems.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·June 11, 2017

    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code KHO·September 28, 2018