Roche Diagnostics Corporation - Cobas c Bilirubin Total Gen.3 - Class 2 Recall
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 14, 2019 Category: Medical Devices Source Type: alerts
Roche Diagnostics Corporation - Roche Diagnostics URISYS 1100 Urine Analyzer - Class 2 Recall
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 1, 2018 Category: Medical Devices Source Type: alerts
Radiometer America Inc - The ABL90 FLEX Analyzer - Class 2 Recall
ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDLab 1265 System - Class 2 Recall
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDPoint 500 System - Class 2 Recall
RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDPoint 405 System - Class 2 Recall
RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total bilirubin and full CO-oximetry from a single sample. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - RAPIDLab 1245 System - Class 2 Recall
RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 25, 2018 Category: Medical Devices Source Type: alerts
Clarity Diagnostics Llc - Clarity Urocheck 10SG Urinalysis Strips - Class 3 Recall
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. The Clarity Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations, and are intended for professional use only. The strips are intended for use in screening at-risk patients to assist diagnosis in the following are...
Source: Medical Device Recalls - July 25, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - iChem(R) VELOCITY Urine Chemistry Strips - Class 2 Recall
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic deice used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH,...
Source: Medical Device Recalls - May 19, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - BECKMAN COULTER iChemVELOCITY - Class 2 Recall
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible ...
Source: Medical Device Recalls - May 5, 2018 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Lyophilized Chemistry Calibrator Level 1 and Level 2 - Class 2 Recall
Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Gluco...
Source: Medical Device Recalls - February 14, 2018 Category: Medical Devices Source Type: alerts
Medtest Holdings, Inc. - Pointe Scientific Hitachi Total Bilirubin Rl Reagent - Class 2 Recall
Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2017 Category: Medical Devices Source Type: alerts
Radiometer America Inc - ABL90 Flex - Class 2 Recall
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2017 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - iChemVELOCITY Automated Urine Chemistry System - Class 2 Recall
iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips (So...
Source: Medical Device Recalls - March 2, 2017 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics, Inc. - Advia Chemistry Systems Calibrator - Class 2 Recall
Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), Total Bilirubin (TBIL_2), Calcium (CA, CA_c, CA_2, CA_2c), Cholesterol (CHOL), Creatinine (CREA, CREA_2, CRE_2c, ECRE_2), Glucose Hexakinase (GLUH), Glucose Oxidase (GLUO), Iron (IRON_2), Lithium (LITH), Magnesium (MG, MG_c), Phosphorus - inorganic (IP, IP_c), Total Protein (TP, TP_c), Triglycerides (TRIG), Urea Nitrogen (UN, UN_c), Uric Acid (UA, UA_c) (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 17, 2016 Category: Medical Equipment Source Type: alerts
