Radiometer America recalls

Radiometer America appears in 25 official U.S. recall notices indexed by RecallRadar, most recently on 2019-08-28.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
  FDA Device · Class II · 2019-08-28 · Radiometer America
• Product: ABL800 FLEX with Crea
  FDA Device · Class II · 2019-02-13 · Radiometer America
• ABL800 analyzer, model numbers 393-800 and 393-801
  FDA Device · Class II · 2019-01-02 · Radiometer America
• ABL90 FLEX analyzers with software versions 3.3MR1 or below
  FDA Device · Class II · 2018-10-10 · Radiometer America
• ABL800 analyzer with FLEXQ module
  FDA Device · Class II · 2017-12-20 · Radiometer America
• AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are…
  FDA Device · Class II · 2017-10-11 · Radiometer America
• The ABL800 Model#:All
  FDA Device · Class II · 2017-03-22 · Radiometer America
• ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oxim…
  FDA Device · Class II · 2017-03-22 · Radiometer America
• AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radi…
  FDA Device · Class II · 2016-12-28 · Radiometer America
• TCM CombiM Modules 903-111
  FDA Device · Class II · 2016-05-11 · Radiometer America
• AQURE System
  FDA Device · Class II · 2016-02-10 · Radiometer America
• Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873
  FDA Device · Class II · 2015-08-26 · Radiometer America
• Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of s…
  FDA Device · Class II · 2015-03-25 · Radiometer America
• ABL90 FLEX analyzer
  FDA Device · Class II · 2015-02-11 · Radiometer America
• HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the…
  FDA Device · Class II · 2014-12-31 · Radiometer America
• RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, sto…
  FDA Device · Class II · 2014-09-17 · Radiometer America
• pCO2 D788 Membranes
  FDA Device · Class II · 2014-03-05 · Radiometer America
• ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, el…
  FDA Device · Class II · 2014-01-29 · Radiometer America
• pO2 D999 membrane units
  FDA Device · Class II · 2014-01-22 · Radiometer America
• Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood
  FDA Device · Class II · 2013-10-09 · Radiometer America
• TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com
  FDA Device · Class II · 2013-08-14 · Radiometer America
• Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042
  FDA Device · Class III · 2013-01-02 · Radiometer America
• The ABL software version 6.12 for the ABL800 and ABL700 analyzer
  FDA Device · Class II · 2012-08-15 · Radiometer America
• ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood
  FDA Device · Class II · 2012-08-15 · Radiometer America
• The ABL software version 6.12 for the ABL800 analyzer
  FDA Device · Class II · 2012-08-15 · Radiometer America