Radiometer America Inc

Complete recall history across all FDA and CPSC categories — 25 total recalls

Radiometer America Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (25)

FDA medical device enforcement actions by Radiometer America Inc

Date Product Reason Class
Jul 10, 2019 ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Software Security; The action is being initiated because of software securit... Class II
Jul 3, 2018 ABL800 analyzer, model numbers 393-800 and 393-801. The analyzer software may cause a mis-match of patient demographics and test ... Class II
Jul 2, 2018 Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the foll... From three incidents in Denmark and Sweden, comparison studies on patient blo... Class II
May 25, 2018 ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX A... The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when th... Class II
Oct 24, 2017 ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of... Due to misinterpretation of the barcode by the scanner, when the registration... Class II
Sep 7, 2017 AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood ga... Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 a... Class II
Jan 26, 2017 The ABL800 Model#:All Reports that the sample type "cord blood" has been changed into the two sampl... Class II
Jan 26, 2017 ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures p... Reports that the sample type "cord blood" has been changed into the two sampl... Class II
Nov 23, 2016 AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335... Design error when displaying additional information in the patient view windo... Class II
Dec 29, 2015 AQURE System; Model Number: 933-599. The AQURE System manages blood gas and ... The AQURE System has a design error regarding sample type in which sample typ... Class II
Nov 18, 2015 TCM CombiM Modules 903-111 Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may h... Class II
Jul 16, 2015 Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873... When the fixation ring is taken off the paper liner there is a potential for ... Class II
Dec 8, 2014 ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer th... The ABL90 analyzer does not always use the most recent calibration data to ca... Class II
Oct 29, 2014 Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL8... Negative drift on QC during in-use lifetime of CREA membranes can be observed. Class II
Oct 20, 2014 HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are... Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide r... Class II
Jul 28, 2014 RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data process... Class II
Oct 15, 2013 ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark ... RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentiall... Class II
Jul 5, 2013 pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. ... RADIOMETER has become aware that some D788 pCO2 membranes can cause biased me... Class II
Jun 10, 2013 pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, O... RADIOMETER became aware that the regarded lot pO2 units 942-042R0971 were pro... Class II
Nov 27, 2012 TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, ... RADIOMETER became aware that the TCM4 series Base Unit does not comply with I... Class II
Oct 8, 2012 Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intend... RADIOMETER became aware that some membranes may have enzyme residue on the ou... Class II
Jul 5, 2012 The ABL software version 6.12 for the ABL800 analyzer. The analyzers are inte... A customer has reported an error on an ABL8xx configured to a Hospital Inform... Class II
Jul 5, 2012 The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyze... A customer has reported an error on an ABL8xx configured to a Hospital Inform... Class II
Jul 5, 2012 ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for... A customer has reported an error on an ABL8xx configured to a Hospital Inform... Class II
Jun 6, 2006 Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The ... The barcode for the ABL77 on the insert incorrectly enters a control range fo... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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