Total recalls 24 since 2012
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 0 latest 28 Aug 2019
Recalls per month, last 24 months click a bar for that month Severity split
0 0%23 96%1 4%
Why radiometer america is recalled
All radiometer america recalls, newest first 24 total Reported Class Recall Company Reason Where 28 Aug 2019 Device CLASS II ABL90 FLEX Analyzer recalled by Radiometer America Radiometer America Device Malfunction 36 states 13 Feb 2019 Device CLASS II ABL800 FLEX with Crea recalled by Radiometer America Radiometer America Other 31 states 2 Jan 2019 Device CLASS II ABL800 analyzer recalled by Radiometer America Radiometer America Device Malfunction Nationwide 10 Oct 2018 Device CLASS II ABL90 FLEX analyzers recalled by Radiometer America Radiometer America Device Malfunction CA 20 Dec 2017 Device CLASS II ABL800 analyzer with Flexq module recalled by Radiometer America Radiometer America Other Nationwide 11 Oct 2017 Device CLASS II AutoCheck5+, Level 2, specifically designed recalled Radiometer America Device Malfunction Nationwide 22 Mar 2017 Device CLASS II The ABL800 recalled by Radiometer America Radiometer America Other Nationwide 22 Mar 2017 Device CLASS II ABL90 Flex recalled by Radiometer America Radiometer America Other Nationwide 28 Dec 2016 Device CLASS II Aqure System recalled by Radiometer America Radiometer America Potency & Assay MI, NY 11 May 2016 Device CLASS II TCM CombiM Modules recalled by Radiometer America Radiometer America Device Malfunction Nationwide 10 Feb 2016 Device CLASS II Aqure System recalled by Radiometer America Radiometer America Potency & Assay Nationwide 26 Aug 2015 Device CLASS II Radiometer Fixation Kit N20 for the TCM CombiM monitoring system recalled Radiometer America Device Malfunction CA 25 Mar 2015 Device CLASS II Crea A and B membranes, packaged 4 per box Used recalled Radiometer America Packaging Defects 27 states 11 Feb 2015 Device CLASS II ABL90 FLEX analyzer recalled by Radiometer America Radiometer America Device Malfunction 41 states 31 Dec 2014 Device CLASS II HemoCue¿ Glucose 201 Microcuvettes recalled by Radiometer America Radiometer America Packaging Defects Nationwide 17 Sep 2014 Device CLASS II Radiance v. 2.4X, 2.5X and 2.6X recalled by Radiometer America Radiometer America Other Nationwide 5 Mar 2014 Device CLASS II pCO2 D788 Membranes recalled by Radiometer America Radiometer America Other Nationwide 29 Jan 2014 Device CLASS II ABL90 FLEX Analyzer Radiometer Medical ApS recalled Radiometer America Other 41 states 22 Jan 2014 Device CLASS II pO2 D999 membrane units recalled by Radiometer America Radiometer America Other Nationwide 9 Oct 2013 Device CLASS II Lactate Membrane units for E7077 Electrode Radiometer Medical ApS recalled Radiometer America Other Nationwide 14 Aug 2013 Device CLASS II TCM4 series Base Units, and spare part Power Supply recalled Radiometer America Device Malfunction Nationwide 2 Jan 2013 Device CLASS III Qualicheck 1+, Aqueous Quality Control, Level 2, S7140 recalled Radiometer America Other KY, NC, NY 15 Aug 2012 Device CLASS II The ABL recalled by Radiometer America Radiometer America Device Malfunction Nationwide 15 Aug 2012 Device CLASS II ABL90 FLEX recalled by Radiometer America Radiometer America Device Malfunction Nationwide
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.