Arkray Factory USA, Inc.: AUTION HYBRID AU-4050

Is my product affected?

AUTION HYBRID AU-4050

• UPC 00015482146030

Check against the official notice below — it lists the full affected range.

What happened

Arkray Factory USA, Inc. is correcting an issue with the AUTION HYBRID AU-4050 instrument due to a software problem. The issue could potentially cause incorrect patient information to be assigned to sample results, but only if a rare combination of three specific events occurs together: a urine sediment measurement error that produces no results, an incorrect instrument shutdown, and the use of an item rack for subsequent sample measurements. This correction affects 159 units distributed in the US.

The source document does not specify what actions affected consumers should take in response to this correction.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Quantity: 159 units Lot/code info: UDI: (01) 00015482146030 All serial numbers

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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