Radiometer America Inc recalls

14 recalls on record · latest: July 10, 2019

Official U.S. recall history for Radiometer America Inc, compiled from official government records.

Get recall alerts

Free email alert whenever Radiometer America Inc has a new recall — straight from official government data. Unsubscribe anytime.

Radiometer America Inc recalls ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

July 10, 2019 · Medical device recalls Moderate risk Software Security; The action is being initiated because of software security v…

Radiometer America Inc recalls ABL800 analyzer, model numbers 393-800 and 393-801.

July 3, 2018 · Medical device recalls Moderate risk The analyzer software may cause a mis-match of patient demographics and test re…

Radiometer America Inc recalls Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and A…

July 2, 2018 · Medical device recalls Moderate risk From three incidents in Denmark and Sweden, comparison studies on patient blood…

Radiometer America Inc recalls ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer…

May 25, 2018 · Medical device recalls Moderate risk The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the…

Radiometer America Inc recalls ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pC…

October 24, 2017 · Medical device recalls Moderate risk Due to misinterpretation of the barcode by the scanner, when the registration r…

Radiometer America Inc recalls AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality contro…

September 7, 2017 · Medical device recalls Moderate risk Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 amp…

Radiometer America Inc recalls ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate,…

January 26, 2017 · Medical device recalls Moderate risk Reports that the sample type "cord blood" has been changed into the two sample…

Radiometer America Inc recalls The ABL800 Model#:All

January 26, 2017 · Medical device recalls Moderate risk Reports that the sample type "cord blood" has been changed into the two sample…

Radiometer America Inc recalls AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE…

November 23, 2016 · Medical device recalls Moderate risk Design error when displaying additional information in the patient view window;…

Radiometer America Inc recalls AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.

December 29, 2015 · Medical device recalls Moderate risk The AQURE System has a design error regarding sample type in which sample type…

Radiometer America Inc recalls TCM CombiM Modules 903-111

November 18, 2015 · Medical device recalls Moderate risk Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may hav…

Radiometer America Inc recalls Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc…

July 16, 2015 · Medical device recalls Moderate risk When the fixation ring is taken off the paper liner there is a potential for fr…

Radiometer America Inc recalls ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes,…

December 8, 2014 · Medical device recalls Moderate risk The ABL90 analyzer does not always use the most recent calibration data to calc…

Radiometer America Inc recalls Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: I…

October 29, 2014 · Medical device recalls Moderate risk Negative drift on QC during in-use lifetime of CREA membranes can be observed.