Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AUTION HYBRID AU-4050 Recalled by Arkray Factory USA, Inc. Due to This correction is being initiated due to a...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arkray Factory USA, Inc. directly.
Affected Products
AUTION HYBRID AU-4050
Quantity: 159 units
Why Was This Recalled?
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.
Where Was This Sold?
US
About Arkray Factory USA, Inc.
Arkray Factory USA, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report