Radiometer ABL800 Blood Gas Analyzer Recall for Sample Type Change
Radiometer America Inc. is recalling ABL800 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 source text describes a software/configuration change regarding sample type labels without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Radiometer America Inc. is recalling the ABL800 blood gas analyzer (Model #: All) due to a change in sample type definitions. The sample type previously labeled as 'cord blood' has been changed into two distinct sample types: 'cord blood arterial' and 'cord blood venous.'
The recall affects 17,522 units with serial numbers ranging from 393-090R0027N001 to present. These devices were distributed nationwide in the United States and in several foreign countries, including the Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.
Users of these devices should contact Radiometer America Inc. for further instructions regarding the update to the sample type definitions.
The recalled product
- Product
- The ABL800 Model#:All
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 17,522
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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