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  • Dispositivo 2589
  • Fabricante 31827
  • Evento 2705
  • Implante 0
1 Step 12 Panel Cup
  • Modelo / Serial
    144408 150675
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Australia.
  • Descripción del producto
    1 Step 12 Panel Cup, Item No. NBCA-12M-W || These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
  • Manufacturer
    Ameditech Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 1 Step 12 Panel Cup
50 mL sterile plastic centerfuge tubes.
  • Modelo / Serial
    Codes 3250, 3250P, 3252, 3252P and the lot numbers: 69766 through 87512 which were manufactured from 02/03/03 - 09/22/2003  Also:  3250-DES1, 3250P-DES1, 3252-DES1, 3252P-DES1  3250P-MIS1, 3252P-MIS1  3250P-USA1, 3252P-USA1
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    50 mL sterile plastic centerfuge tubes.
  • Manufacturer
    Stockwell Scientific Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 50 mL sterile plastic centerfuge tubes.
5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)List Number: 04J71-20Lot Numbers: 56944001, 57026001, 57059001 and 57673001
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Abbott Australasia Pty Ltd Molecular Division
  • 1 Event
    • Retiro De Equipo (Recall) de 5mL Reaction Vessels used with the m2000sp Instrument. An in vitro diagnostic medical device (IVD)
862.2160 Discrete photometric chemistry analyzer
  • Modelo / Serial
    Part Number: 386167 Lot Number: 04250160
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    FL, HI, IL, MS, MI, NC, NY, OH, OK, TX, UT, VA, WI, and Canada
  • Descripción del producto
    UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels).
  • Manufacturer
    Beckman Coulter Inc
  • 1 Event
    • Retiro De Equipo (Recall) de 862.2160 Discrete photometric chemistry analyzer
ABBOTT ARCHITECT System Software
  • Modelo / Serial
    List numbers 5F48-22 and 5F48-23, part numbers 7-204717-01 and 7-204717-02 when used with 7-94255-01 and 7-200788-01.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide.
  • Descripción del producto
    ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. || The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology.
  • Manufacturer
    Abbott Laboratories, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ABBOTT ARCHITECT System Software
Abbott AxSYM Matrix Cells
  • Modelo / Serial
    Lot # 37618Q100 Expiration Date 12/05/2006
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide including the states of AL, AK, AZ, CA, CT, CO, DE, FL, GA, ID, IL, IA, IN, KS, KY, LA, MA, ME, MI, MS, MN, MT, MO, NM, NJ, NY, NV, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, Hawaii and Puerto Rico
  • Descripción del producto
    Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100
  • Manufacturer
    Abbott Diagnostic International, Ltd.
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott AxSYM Matrix Cells
Abbott Clinical Chemistry Aeroset/Architect Bilirubin Calibrator
  • Modelo / Serial
    List Number (LN) 1E66-03 Lot Number: 38436M100 (Expires September 30, 2007); List Number (LN) 1E66-04 Lot Numbers: 41456M100 (Expires December 31, 2007), 42396M100 (Expires April 30, 2008), 48616M100 (Expires July 31, 2007)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: USA, Canada, Mexico, Guatemala, Puerto Rico, Germany, Hong Kong, Singapore, Australia, New Zealand, Jamaica, Venezuela, Columbia, Ecuador, Chile, Uruguay, Argentina, Brazil, Thailand, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, and El Salvador
  • Descripción del producto
    Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Clinical Chemistry Aeroset/Architect Bilirubin Calibrator
Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
  • Modelo / Serial
    Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
  • Descripción del producto
    Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
  • Manufacturer
    Abbott Laboratories Diagnostic Div
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
  • Modelo / Serial
    This is not a lot specific issue.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide and to Mexico, Brazil, Sinagapore, Venezuela, Puerto Rico, Hong Kong, Colombia, Dominican Republic, Australia, Ecuador, Canada, New Zealand, Argentina, Germany, Bahamas, Grand Cayman, El Salvador.
  • Descripción del producto
    Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
  • Manufacturer
    Abbott Laboratories Diagnostic Div
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
Abbott Clinical Chemistry Bil Cal
  • Modelo / Serial
    List # 1E66-03; Lot #20881M100
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
  • Descripción del producto
    Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
  • Manufacturer
    Abbott Laboratories Diagnostic Div
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Clinical Chemistry Bil Cal
ABBOTT Clinical Chemistry Calibrator
  • Modelo / Serial
    Lot Number: 61388M100, 57919M100, 54754M100, and 52632M100.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including United States, Mexico, Columbia, Uruguay, Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina, Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador, Singapore, Australia, Curacao and Cayman Island.
  • Descripción del producto
    ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. || The device is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The product is used to calibrate assays used to determine bilirubin concentrations in neonate and adult patient samples.
  • Manufacturer
    Abbott Laboratories Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de ABBOTT Clinical Chemistry Calibrator
Abbott Clinical Chemistry Urea Nitrogen
  • Modelo / Serial
    Urea Nitrogen 7D75-21 (lot 97642UN11) and Urea Nitrogen 7D75-31 (lot 97668UN11)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
  • Manufacturer
    Abbott Laboratories, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Clinical Chemistry Urea Nitrogen
Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System
  • Modelo / Serial
    39074HW00 (exp. 9/30/06), 41008HW00 (exp. 10/31/06), 42063HW00 (exp. 12/31/06)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia
  • Descripción del producto
    Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
  • Manufacturer
    Abbott Laboratories Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System
Abbott Laboratories HbA1c Calibrators
  • Modelo / Serial
    List Number: 4P52-02;  Lot Number: 45063UQ12;  Expiration Date: 15 DEC 2014
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.
  • Descripción del producto
    HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. || For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
  • Manufacturer
    Abbott Laboratories
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Laboratories HbA1c Calibrators
Abbott m2000rt System software
  • Modelo / Serial
    catalog #09K15-01, all software versions are affected.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belgium, Benin, Bolivia, Bosnia and Herzegovia, Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dem. Rep. of the Congo, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Gabon, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Libya, Lithuania, Malawi, Malaysia, Mali, Mauritius, Mexico, Moldova, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Yemen, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Venezuela, Vietnam, Zambia and Zimbabwe
  • Descripción del producto
    Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des Plaines, IL 60018 USA; catalog #09K15-01 || The Abbott m2000rt System provides for real-time measurement of the stages of the polymerase chain reaction (PCR). Real-time PCR measures PCR amplification as it occurs, cycle-by-cycle, allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR.
  • Manufacturer
    Abbott Molecular
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott m2000rt System software
Abbott m2000sp Instrument
  • Modelo / Serial
    list 09K14, all serial numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the countries of Algeria, Australia, Austria, Azerbaijan, Belgium, Brazil, Burundi, Cameroon, China, Croatia, Estonia, Ethiopia, Finland, France, Gaza & Jericho, Germany, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Libya, Malawi, Malaysia, Mali, Mozambique, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Vietnam and Zambia
  • Descripción del producto
    Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
  • Manufacturer
    Abbott Molecular
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott m2000sp Instrument
Abbott Molecular Abbott m2000sp
  • Modelo / Serial
    List Number: 09K14; Models: E series, G series
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. US nationwide (CA, CT, FL, NC, PA, SC, and DC), Algeria , Australia , Austria , Belgium , Bosnia and Herzegovina , Cameroon , Canada , Chad , Colombia , Costa Rica , Croatia , Denmark , Egypt , Ethiopia , Finland , France , Germany , Greece , Guinea , Honduras , Hong Kong , India , Indonesia , Ireland , Israel , Italy , Japan , Kenya , Korea , Lithuania , Mali , Mexico , Netherlands , New Zealand , Nigeria , Norway , Pakistan , Paraguay , Poland , Portugal , Romania , Russia , Saudi Arabia , Senegal , Slovenia , South Africa , Spain , Sweden , Switzerland , Taiwan , Tanzania , Thailand , Turkey , Uganda , Ukraine , United Arab Emirates, United Kingdom , Vietnam
  • Descripción del producto
    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
  • Manufacturer
    Abbott Molecular
  • 1 Event
    • Retiro De Equipo (Recall) de Abbott Molecular Abbott m2000sp
ABBOTT TestPack Plus hCG Combo
  • Modelo / Serial
    list 3A60-16, lot 17597M200, exp. 10/25/05
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    This product is not distributed in the U.S. It was distributed internationally to Canada, Germany, Honduras, Nicaragua, the Bahamas, the Philippines (via Singapore), New Zealand, and Uruguay
  • Descripción del producto
    ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA
  • Manufacturer
    Abbott Laboratories MPG
  • 1 Event
    • Retiro De Equipo (Recall) de ABBOTT TestPack Plus hCG Combo
ABL5
  • Modelo / Serial
    Model Catalog: 906-018 (Lot serial: 041643 - 045124)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Descripción del producto
    ABL5 BLOOD GAS ANALYZER
  • Manufacturer
    RADIOMETER AMERICA INC.
  • 1 Event
    • Retiro De Equipo (Recall) de ABL5
ABL7XX Calibration 1 Solution S1720
  • Modelo / Serial
    P/N S1720, 944-024; Lot: WA-04
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
  • Descripción del producto
    ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 || Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.
  • Manufacturer
    Radiometer America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ABL7XX Calibration 1 Solution S1720
ABL800 blood gas analyzer
  • Modelo / Serial
    All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA and Canada.
  • Descripción del producto
    ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
  • Manufacturer
    Radiometer America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ABL800 blood gas analyzer
ABL800 FLEX
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.
  • Descripción del producto
    ABL800 analyzer with FLEXQ module. || Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
  • Manufacturer
    Radiometer America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ABL800 FLEX
ABL90 FLEX Analyzer Radiometer Medical ApS
  • Modelo / Serial
    Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
  • Descripción del producto
    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 || Br¿nsh¿j, Denmark || A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
  • Manufacturer
    Radiometer America Inc
  • 1 Event
    • Retiro De Equipo (Recall) de ABL90 FLEX Analyzer Radiometer Medical ApS
ABX PENTRA AST CP,
  • Modelo / Serial
    Lot number: 00456-4108
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
  • Descripción del producto
    ABX PENTRA AST CP, Part Number: A11A01629. || The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX PENTRA AST CP,
ABX PENTRA Calcium CP Reagent, Model A11A01633
  • Modelo / Serial
    Lot/Serial #(s): 014664503
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the country of Canada.
  • Descripción del producto
    ABX PENTRA Calcium CP Reagent, Model # A11A01633 || Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical
  • 1 Event
    • Retiro De Equipo (Recall) de ABX PENTRA Calcium CP Reagent, Model A11A01633
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