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.
What this means for you
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
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