Radiometer America Inc
13 recalls on record · Latest: Jan 2, 2019
Radiometer America Inc Recall Insight
Radiometer America Inc appears on 13 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.015% 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 Jan 2, 2019, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 13 entries, severity tagging shows 0 critical, 12 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 13 of 13 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 (13). The date window on this page runs from Aug 15, 2012 to Jan 2, 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.
ABL800 analyzer, model numbers 393-800 and 393-801.
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifica…
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry …
TCM CombiM Modules 903-111
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…
HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue G…
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…
pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantif…
Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
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…
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…
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Other firms with recall activity tracked in the PlainRecalls index.
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