PlainRecalls

Radiometer America Inc

Compiled from official public sources by the editorial team.

25 recalls on record · Latest: Aug 28, 2019

Radiometer America Inc Recall Insight

Radiometer America Inc appears on 25 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.025% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Aug 28, 2019, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 25 entries, severity tagging shows 0 critical, 24 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 25 of 25 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (25). The date window on this page runs from Aug 15, 2012 to Aug 28, 2019.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Aug 28, 2019

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

FDA Devices Moderate Feb 13, 2019

Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 3…

FDA Devices Moderate Jan 2, 2019

ABL800 analyzer, model numbers 393-800 and 393-801.

FDA Devices Moderate Oct 10, 2018

ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases,…

FDA Devices Moderate Dec 20, 2017

ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl ,…

FDA Devices Moderate Oct 11, 2017

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifica…

FDA Devices Moderate Mar 22, 2017

ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry …

FDA Devices Moderate Mar 22, 2017

The ABL800 Model#:All

FDA Devices Moderate Dec 28, 2016

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 Radiome…

FDA Devices Moderate May 11, 2016

TCM CombiM Modules 903-111

FDA Devices Moderate Feb 10, 2016

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

FDA Devices Moderate Aug 26, 2015

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 tc Sensor 5…

FDA Devices Moderate Mar 25, 2015

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 samples of…

FDA Devices Moderate Feb 11, 2015

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin a…

FDA Devices Moderate Dec 31, 2014

HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue G…

FDA Devices Moderate Sep 17, 2014

RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, re…

FDA Devices Moderate Mar 5, 2014

pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantif…

FDA Devices Moderate Jan 29, 2014

ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electroly…

FDA Devices Moderate Jan 22, 2014

pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2 membrane units, ordering number 942-042 Intended use is in …

FDA Devices Moderate Oct 9, 2013

Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

FDA Devices Moderate Aug 14, 2013

TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are int…

FDA Devices Low Jan 2, 2013

Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.

FDA Devices Moderate Aug 15, 2012

ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

FDA Devices Moderate Aug 15, 2012

The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood f…

FDA Devices Moderate Aug 15, 2012

The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the para…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Radiometer America Inc with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.