Overview of recall records associated with Radiometer Medical ApS, including dates, categories and classifications where available.
Classification mix: Class II: 25.
ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample…
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result…
Due to potential software issue that may result in patient mix-up information.
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70…
Potential risk of patient mix-up on analyzers due to software issues.
Potential risk of patient mix-up on analyzers due to software issues.
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode…
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode…
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt,…
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt,…
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply…
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the…
The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the…
Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as…
Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This…
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party…
This page summarizes recall records in which the official source identifies Radiometer Medical ApS as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
