Brand

Radiometer America Inc Recalls

11 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Radiometer America Inc.

11Total Recalls
0Critical
3.8MUnits Affected
Jul 3, 2018Most Recent
All Recalls

Every Radiometer America Inc Recall

Sorted by most recent. Click any recall for full details.

11 recalls
High RiskFDA
Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Medical Devices·2,131 affected·Jul 3, 2018
High RiskFDA
Radiometer America Inc
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules a...
Medical Devices·1,669 affected·Sep 7, 2017
High RiskFDA
Radiometer America Inc
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, a...
Diabetes Devices·9,688 affected·Jan 26, 2017
High RiskFDA
Radiometer America Inc
TCM CombiM Modules 903-111
Medical Devices·1,488 affected·Nov 18, 2015
High RiskFDA
Radiometer America Inc
Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and...
Respiratory Devices·4,244 affected·Jul 16, 2015
High RiskFDA
Radiometer America Inc
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and t...
Diabetes Devices·3,712,900 affected·Oct 20, 2014
High RiskFDA
Radiometer America Inc
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify...
Medical Devices·38,890 affected·Jul 5, 2013
High RiskFDA
Radiometer America Inc
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Medical Devices·13,632 affected·Oct 8, 2012
High RiskFDA
Radiometer America Inc
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Medical Devices·1,427 affected·Jul 5, 2012
High RiskFDA
Radiometer America Inc
The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of w...
Medical Devices·6,854 affected·Jul 5, 2012
RecallFDA
Radiometer America Inc
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Medical Devices·840 affected·Jun 6, 2006