Manufacturer
25 recalls in our database name Radiometer America Inc as the manufacturing or recalling firm.
Of the 25 recalls from Radiometer America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Radiometer America Inc is recalling ABL90 FLEX Analyzers due to software security vulnerabilities that may cause device shutdowns or reboots, potentially delaying medical treatment.
Radiometer America Inc. is recalling ABL800 FLEX analyzers because creatinine measurements may be underestimated by up to 28%, potentially affecting patient safety during radiocontrast x-ray investigations.
Radiometer America Inc is recalling 2,131 ABL800 analyzers because software may cause a mismatch between patient demographics and test results.
Radiometer America Inc. is recalling ABL90 FLEX analyzers with software version 3.3MR1 or below because they may aspirate calibration solution instead of rinse solution.
Radiometer America Inc. is recalling 1,749 ABL800 analyzers because a barcode scanner error may display results from a different patient.
Radiometer America is recalling AutoCheck5+ Level 2 quality control ampoules because they may provide incorrect pCO2 and pO2 results.
Radiometer America Inc. is recalling ABL90 Flex analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'
Radiometer America Inc. is recalling ABL800 analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'
Radiometer America Inc is recalling AQURE System software due to a design error that may cause users to misread patient parameters and values.
Radiometer America is recalling TCM CombiM Modules 903-111 because the alarm may sound louder than the pre-set maximum volume.
Radiometer America Inc is recalling 375 AQURE Systems (Model 933-599) because a design error may leave the sample type field blank, potentially leading to misinterpretation of blood gas and immunoassay results.
Radiometer America Inc is recalling Fixation Kit N20 units because paper liner coating may stick to the fixation ring.
Radiometer America Inc. is recalling Crea A and B membranes used with ABL800 FLEX analyzers due to negative drift on quality control during their in-use lifetime.
Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.
Radiometer America Inc. is recalling HemoCue Glucose 201 Microcuvettes because they show discoloration and provide results outside specification near the end of their shelf life.
Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.
Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.
Radiometer America Inc is recalling ABL90 FLEX analyzers because tilting the device may cause negative bias in sodium results.
Radiometer America is recalling pO2 D999 membrane units because they were produced with the wrong inner solution, causing calibration failures.
Radiometer America Inc. is recalling Lactate Membrane units for the E7077 Electrode due to potential enzyme residue that may cause inaccurate test results.
Radiometer America Inc is recalling TCM4 series Base Units and Power Supplies because they do not comply with IEC 60601-1 Sub Clause 15B electrical safety standards.
Radiometer America Inc is recalling Qualicheck 1+ quality control solution due to a barcode error that incorrectly enters a pH control range into blood gas analyzers.
Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3 because a data transfer error can cause mixed-up results when transmitting to hospital systems.
Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.
Radiometer America Inc. is recalling ABL software version 6.12 for ABL800 and ABL700 analyzers because HL7 2.5 data transmission errors can mix up queued results.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Radiometer
Danish company
Source: Wikidata (Q2126439), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.