Arkray Factory USA, Inc. AUTION HYBRID AU-4050 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AUTION HYBRID AU-4050
Brand
Arkray Factory USA, Inc.
Lot Codes / Batch Numbers
UDI: (01) 00015482146030 All serial numbers
Products Sold
UDI: (01) 00015482146030 All serial numbers
Arkray Factory USA, Inc. is recalling AUTION HYBRID AU-4050 due to This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
Recommended Action
Per FDA guidance
The firm initiated the field correction by email on 05/03/2019. The letter stated how to recognize a product failure and the actions to be taking by the customer until the software upgrade is ready for installation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026