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    Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 16, 2009

    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·February 16, 2016

    AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.

    FDA Recall
    Terminated ·AMS Diagnostics, LLC·Product code NJT·February 11, 2014

    VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CDN·June 12, 2013

    AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code CDQ·November 24, 2003

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Recall
    Terminated ·Derma Pen, LLC·Product code PIU·February 5, 2015

    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CDS·October 31, 2016

    Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.

    FDA Recall
    Terminated ·Sterling Diagnostics, Inc.·Product code CDL·July 20, 2016

    Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct); List No: 06F05-01; Part No: 121000; Abbott Point of Care Inc., East Windsor, NJ 08520 USA; Product of Canada.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JGS·October 18, 2007

    Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista System

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·September 15, 2016

    Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct); List No: 06F04-01; Part No: 12500; Abbott Point of Care Inc., East Windsor, NJ 08520, USA; Product of Canada.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JGS·October 18, 2007

    Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·August 31, 2009

    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

    FDA Recall
    Terminated ·Arkray Factory USA, Inc.·Product code CGA·December 18, 2015

    i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·January 15, 2020

    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

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·February 28, 2014

    i-STAT Level 2 Control Value Assignment Sheets Human Consumption

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code JJY·August 3, 2010

    Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHL·September 12, 2014

    cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code CEM·February 22, 2018

    cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code CEM·February 22, 2018

    cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code CEM·February 22, 2018