Radiometer ABL90 FLEX Analyzer Recalled for Potential Sodium Measurement Bias
Radiometer America Inc is recalling ABL90 FLEX analyzers because tilting the device may cause negative bias in sodium 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 involves a high-risk medical device where a measurement error could impact patient care, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Radiometer America Inc is recalling the ABL90 FLEX Analyzer, a portable, automated medical device used to measure pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. The recall was initiated because the company became aware that tilting the analyzer may potentially cause a negative bias on sodium (Na+) results.
The recall affects a total of 3,414 units, including 524 in the United States, 31 in Canada, and 2,859 in other regions. The affected units are identified by Lot R0375N009, Model #393-090, and serial numbers ranging from 393-090R0027N001 to 393-090R0379N010. Distribution was worldwide, including various U.S. states and international locations such as Australia, Canada, China, and the United Kingdom.
Healthcare facilities and users should check their inventory for the specific lot and serial numbers listed. If the device is found, it should be removed from use and returned to Radiometer America Inc according to their instructions to prevent potential inaccuracies in sodium measurements.
The recalled product
- Product
- ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
- Manufacturer
- Radiometer America Inc
- Hazard
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 (3)
- Lot R0375N009
- Model #393-090
- S/N 393-090R0027N001 - 393-090R0379N010
Distribution
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