The Recall Desk
ModerateFDA (Devices)·Z-1850-2019·Announced 2019-06-26

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.

What this means for you

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.
Category
Medical Device — Laboratory Equipment
Hazard
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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