62 results
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Sources: EU EUDAMED, US FDA
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Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc·July 19, 2017
Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JIX·May 15, 2017
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
CryoValve, Pulmonary Valve and Conduit
FDA Recall
Terminated
·Cryolife Inc·Product code MIE·January 12, 2005
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 Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·November 27, 2013
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
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 Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·December 7, 2016
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 Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 18, 2016
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014
ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·June 13, 2018
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
FDA Enforcement
Class III
·Terminated·Acumedia Manufacturers, Inc.·June 14, 2017
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 Enforcement
Class III
·Terminated·Sterling Diagnostics, Inc.·January 4, 2017
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
FDA Enforcement
Class III
·Terminated·Beckman Coulter Inc.·October 31, 2012
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
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 Enforcement
Class I
·Terminated·Arkray Factory USA, Inc.·January 27, 2016
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015
Clinical Chemistry Urea Nitrogen List Number 7D75-21 and 7D75-31 used for the Quantitation of urea nitrogen in human serum, plasma, and urine.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CDQ·October 3, 2011
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
FDA Recall
Terminated
·Acumedia Manufacturers, Inc.·Product code JSI·September 25, 2016
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 Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·February 26, 2020
Clinical Chemistry Urea Nitrogen
FDA Recall
Terminated
·Abbott Laboratories Diagnostic Div·November 24, 2003