Radiometer ABL90 Flex Analyzer Recalled for Sample Type Labeling Change
Radiometer America Inc. is recalling ABL90 Flex analyzers because the 'cord blood' sample type was changed to 'cord blood arterial' and 'cord blood venous.'
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 specific issue is a change in sample type labeling without reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Radiometer America Inc. is recalling the ABL90 Flex portable, automated analyzer (Model #: 393-090). The device is used to measure pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
The recall is due to reports that the sample type 'cord blood' has been changed into the two sample types 'cord blood arterial' and 'cord blood venous.' The affected analyzers are serial numbers 393-090R0027N001 to present. A total of 9,688 units were distributed nationwide in the U.S. and to various foreign countries including the Netherlands, China, and Germany.
Consumers and healthcare facilities should contact Radiometer America Inc. for further instructions regarding the recall.
The recalled product
- Product
- ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 9,688
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)
- The affected analyzers are serial numbers 393-090R0027N001 to present.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Radiometer America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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