Draeger Medical, Inc. - Babytherm 8004/8010 - Class 2 Recall
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care units. Therapy and nursing uses: - As a resuscitation table and in birthing rooms, obstetric units, and NICUs - As infant warmer...
Source: Medical Device Recalls - July 29, 2016 Category: Medical Equipment Source Type: alerts
Beckman Coulter Inc. - iChem 10 SG Urine Chemistry Strips - Class 2 Recall
iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2016 Category: Medical Equipment Source Type: alerts
Roche Diagnostics Operations, Inc. - S2 Fluid Pack as a part of the cobas b221 Roche OMNI S systems - Class 2 Recall
S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes 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, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 6, 2015 Category: Medical Equipment Source Type: alerts
Abbott Laboratories Inc. - Abbott Clinical Chemistry Aeroset/Architect Bilirubin Calibrator - Class 2 Recall
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 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts
Radiometer America Inc - ABL90 FLEX analyzer - Class 2 Recall
ABL90 FLEX analyzer; Model number 393-090. A 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 - February 10, 2015 Category: Medical Equipment Source Type: alerts
Radiometer America Inc - ABL90 FLEX Analyzer Radiometer Medical ApS - Class 2 Recall
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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 24, 2014 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics - Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent - Class 2 Recall
Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Product usage: Usage: DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2013 Category: Medical Equipment Source Type: alerts
Ortho-Clinical Diagnostics - VITROS Chemistry Products TBIL Slides - Class 2 Recall
VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2013 Category: Medical Equipment Source Type: alerts
Ortho-Clinical Diagnostics - VITROS Chemistry Products BuBc Slides - Class 2 Recall
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 16, 2013 Category: Medical Equipment Source Type: alerts
Microgenics Corporation - Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems - Class 2 Recall
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine - Class 3 Recall
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens ChekStix Combo Pak - Class 2 Recall
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens ChekStix Combo Pak - Class 3 Recall
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens ChekStix Positive and Negative Control Strips for Urine Chemistry - Class 3 Recall
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2013 Category: Medical Equipment Source Type: alerts
Siemens Healthcare Diagnostics Inc - Siemens ChekStix Positive and Negative Control Strips - Class 3 Recall
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 5, 2013 Category: Medical Equipment Source Type: alerts
