Radiometer ABL90 FLEX Analyzers Recalled for Fluid Aspiration Error
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect in fluid aspiration that is theoretical in terms of direct harm without reported adverse events, fitting the criteria for a moderate severity score.
Plain-English summary
Radiometer America Inc. is recalling 12,102 ABL90 FLEX analyzers equipped with software versions 3.3MR1 or below. These portable, automated analyzers are intended for use in laboratory, near-patient, or point-of-care settings to measure pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. The units were distributed in the United States and Canada.
The recall is due to a defect where the analyzer may aspirate Cal 2 solution instead of rinse solution. This error can occur when the analyzer is in ready mode, the operator lifts the inlet and closes it to initiate a rinse, and then immediately lifts the inlet and quickly closes it again.
The source text does not specify instructions for consumers or healthcare providers regarding the recall action. No illnesses or injuries are reported in the provided text.
The recalled product
- Product
- ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment…
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 12,102
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ABL90 FLEX analyzers with software versions 3.3MR1 or below.
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Radiometer America Inc
See all →- HighRadiometer ABL90 FLEX Analyzer Recalled for Software Security Vulnerabilities
FDA (Devices) · 2019-08-28
- HighRadiometer ABL800 FLEX Recalled for Underestimated Creatinine Measurements
FDA (Devices) · 2019-02-13
- HighRadiometer ABL800 Analyzer Recalled for Potential Patient Data Mismatch
FDA (Devices) · 2019-01-02
- HighRadiometer ABL800 Analyzer Recalled for Barcode Misinterpretation
FDA (Devices) · 2017-12-20
- ModerateRadiometer AutoCheck5+ Level 2 Quality Control Ampoules Recalled for Inaccurate Results
FDA (Devices) · 2017-10-11
Similar recalls
- HighRadiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors
FDA (Devices) · 2015-02-11
- ModerateRadiometer ABL90 Flex Analyzer Recalled for Sample Type Labeling Change
FDA (Devices) · 2017-03-22
- HighRadiometer ABL90 FLEX Analyzer Recalled for Potential Sodium Measurement Bias
FDA (Devices) · 2014-01-29
- HighABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results
FDA (Devices) · 2024-07-31
- HighRadiometer ABL800 Analyzer Recalled for Barcode Misinterpretation
FDA (Devices) · 2017-12-20
- HighRadiometer ABL800 FLEX Blood Gas Analyzer Barcode Reader Recall
FDA (Devices) · 2020-04-15