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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
Device Recall Tosoh ST AIAPACK HbA1c Pretreatment Solution
  • Modelo / Serial
    All lots.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Descripción del producto
    Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 || The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
  • Manufacturer
    Tosoh Bioscience Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Tosoh ST AIAPACK HbA1c Pretreatment Solution
Device Recall PO2 electrode
  • Modelo / Serial
    All PO2 electrodes are affected.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    United States
  • Descripción del producto
    PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PO2 electrode
Device Recall AxSYM
  • Modelo / Serial
    List no. 3B34-20
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • Descripción del producto
    AxSYM Tricyclic Antidpressants Reagent. Distributied under the following label: || AxSYM || Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
    Abbott Health Products, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall AxSYM
Device Recall ADx
  • Modelo / Serial
    List no. 9681-55
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • Descripción del producto
    ADx Tricyclic Antidepressants Reagent. || Distributed under the following label: || ADx, Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
    Abbott Health Products, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ADx
Device Recall TDx/TDxFLx
  • Modelo / Serial
    List no. 9681-60
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • Descripción del producto
    TDx/TDxFLx || TDx/TDxFLX Tricyclic Antidepressant Reagent || Distributed under the following label: || TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
    Abbott Health Products, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TDx/TDxFLx
Device Recall Vitros
  • Modelo / Serial
    T3606, Exp 31 Mar 2004
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide distribution to medical facilities, distributors, and U.S. government consignees (39).
  • Descripción del producto
    CARTON LABEL: ''TDM Performance Verifier I''; 6 x 2 mL vials **** Catalog Number 896 2540 **** Made in USA by Ortho-Clinical Diagnostics , Inc., 100 Indigo Creek Drive, Rochester, NY 14626 ****
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitros
Device Recall Vitros Universal Wash Reagent
  • Modelo / Serial
    Lot 5003, Exp. 12 September 2003
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Product was shipped to medical facilities nationwide. There were 6 federal government consignees shipped product under government contract #V797-6565A. No product was shipped outside the U.S.
  • Descripción del producto
    Vitros Immunodiagnostic Products *** UNIVERSAL WASH REAGENT *** for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793
  • Manufacturer
    Ortho-Clinical Diagnostics
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Vitros Universal Wash Reagent
Access 2 Immunoassay System
  • Modelo / Serial
    All fielded instruments.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    Access 2 Immunoassay System
  • Manufacturer
    Beckman Coulter Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Access 2 Immunoassay System
Access 2 immunoassay side of LXi 725
  • Modelo / Serial
    All fielded instruments.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    Access 2 immunoassay side of LXi 725
  • Manufacturer
    Beckman Coulter Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Access 2 immunoassay side of LXi 725
Aeroset Direct HDL Reagent, LN 7D67-01
  • Modelo / Serial
    Lot 86027HW00, Exp Date May 14, 2003 Lot 89150HW00, Exp Date September 13, 2003
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.
  • Descripción del producto
    Aeroset Direct HDL Reagent, LN 7D67-01
  • Manufacturer
    Abbott Laboratories Diagnostic Div
  • 1 Event
    • Retiro De Equipo (Recall) de Aeroset Direct HDL Reagent, LN 7D67-01
Device Recall Cerebrospinal Fluid Test Kit
  • Modelo / Serial
    Lot #204016, Exp 09 NOV 02
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    The kits were shipped to one (1) consignee located in California.
  • Descripción del producto
    Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.
  • Manufacturer
    PerkinElmer LIfe Sciences Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Cerebrospinal Fluid Test Kit
Device Recall Modular P
  • Modelo / Serial
    All units with current software versions (v 06-06 and 07-01).
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    United States
  • Descripción del producto
    Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Modular P
Device Recall Clinitek
  • Modelo / Serial
    serial numbers 168252 through 169574.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    United States, Australia, Canada, Colombia, France, Germany, Hong Kong, India, Japan, Korea, Mexico, Sweden, Switzerland and United Kingdom.
  • Descripción del producto
    Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed.]
  • Manufacturer
    Bayer HealthCare LLC, Diagnostics Div
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Clinitek
Roche brand Cardiac Reader.
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    United States.
  • Descripción del producto
    Roche brand Cardiac Reader.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Roche brand Cardiac Reader.
Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and dist...
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016.
Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and dist...
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112349180, Part number BP5186.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112349180, Part number BP5186.
Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and dist...
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA sy...
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer part number T01-3606-01, Mfd for Bayer Corporation, 511 Benedict Ave, Tarrytown, NY., Roche part number 03361322001.
Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyt...
  • Modelo / Serial
    All units.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte ...
  • Modelo / Serial
    All units. (Sold only outside of the U.S. by Sysmex in Japan.)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182.
Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche...
  • Modelo / Serial
    All units. (Sold only outside of the U.S. by Vital in Netherlands).
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay.
  • Descripción del producto
    Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001.
Device Recall Perkin Elmer DBS MICROPLATE
  • Modelo / Serial
    Lot Numbers: 618609
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    DBS MICROPLATE, TRUNCATED V-BOTTOMED || Product Number: 3033-0010
  • Manufacturer
    Perkinelmer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Perkin Elmer DBS MICROPLATE
Device Recall Perkin Elmer Microplate
  • Modelo / Serial
    Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Microplate, truncated V-bottomed lots included in the || above listed products || Product Number: 1380 5465. || DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
  • Manufacturer
    Perkinelmer
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Perkin Elmer Microplate
Device Recall Omni Microelectrode for cobas b221 analyzer
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Worldwide Distribution - USA nationwide including PR and the country of Guam.
  • Descripción del producto
    Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: || 03111873180 as a part of the following systems: || 1. 03337103001, cobas b 221<1>Roche OMNI S1 system || 2. 03337111001, cobas b 221<2>Roche OMNI S2 system || 3. 03337154001,cobas b 221<6>Roche OMNI S6 system || 4. 03337138001, cobas b 221<4>Roche OMNI S4 system || Product Usage: Usage: || Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Omni Microelectrode for cobas b221 analyzer
Device Recall BD Microtainer Tube
  • Modelo / Serial
    Catalog Number 365992 Lot numbers: 6139630, 6213209, 6296815 and 7059245
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Distribución
    Worldwide; USA, Canada, Australia, Chile, Columbia, Japan, Malaysia, New Zealand, Singapore, Bangladesh and Indonesia
  • Descripción del producto
    BD Microtainer Tube with Glycolytic Inhibitor, Catalog Number 365992, Non Sterile, 200 (4 x 50), 25 degrees C, Becton Dickinson and Company, Franklin Lakes, NJ
  • Manufacturer
    Becton Dickinson & Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall BD Microtainer Tube
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