Radiometer ABL90 FLEX Analyzer Recall for Calibration Data Errors
Radiometer America Inc. is recalling ABL90 FLEX analyzers because they may not use the most recent calibration data, potentially leading to biased patient results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device that may provide biased patient results, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Radiometer America Inc. is recalling the ABL90 FLEX analyzer, model number 393-090. This portable, automated analyzer is used to measure pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. The recall affects 5,002 units with serial numbers ranging from 393-090R0027N001 to present.
The recall was initiated because the ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This defect can, in some cases, lead to a biased patient result. The affected devices were distributed worldwide, including in the United States and numerous international locations.
Healthcare facilities and users should contact Radiometer America Inc. for further instructions regarding the recall and replacement or repair of the affected units.
The recalled product
- Product
- ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
- Manufacturer
- Radiometer America Inc
- Affected units
- 5,002
Distribution
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
- ModerateRadiometer ABL90 FLEX Analyzers Recalled for Fluid Aspiration Error
FDA (Devices) · 2018-10-10
- HighRadiometer ABL800 Analyzer Recalled for Barcode Misinterpretation
FDA (Devices) · 2017-12-20
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateRadiometer ABL90 FLEX Analyzers Recalled for Fluid Aspiration Error
FDA (Devices) · 2018-10-10
- 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 ABL90 FLEX PLUS Analyzer Recalled Due to Barcode Misinterpretation
FDA (Devices) · 2020-04-29
- HighRadiometer ABL90 FLEX Plus Analyzers Recalled for Measurement Errors
FDA (Devices) · 2020-06-03