Arkray AUTION HYBRID AU-4050 Recalled for Software Error
Arkray Factory USA, Inc. is recalling 159 AUTION HYBRID AU-4050 units due to a software issue that could assign incorrect patient information to sample 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 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, and the hazard is a theoretical risk of incorrect data assignment requiring a rare combination of events, with no reported injuries or illnesses.
Plain-English summary
Arkray Factory USA, Inc. is recalling 159 units of the AUTION HYBRID AU-4050 medical device. The recall is initiated due to a software issue that creates the possibility of incorrect patient information being assigned to sample results.
This issue occurs only when a rare combination of three specific events happens: no measurement results are generated due to an error by a urine sediment measurement, the instrument is shut down incorrectly, and an item rack is used for subsequent sample measurements. The affected units are distributed in the US and are identified by UDI (01) 00015482146030 and all serial numbers.
Healthcare facilities should contact Arkray Factory USA, Inc. for instructions on how to address the software issue and ensure patient data integrity.
The recalled product
- Product
- AUTION HYBRID AU-4050
- Manufacturer
- Arkray Factory USA, Inc.
- Affected units
- 159
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)
- UDI: (01) 00015482146030 All serial numbers
Distribution
Distribution scope not specified by the agency.
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