Arkray Factory USA, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1850-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

AUTION HYBRID AU-4050

Product Classification:

Class II

Date Initiated: May 3, 2019

Date Posted: June 26, 2019

Recall Number: Z-1850-2019

Event ID: 82737

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.

Status: Terminated

Product Quantity: 159 units

Code Information:

UDI: (01) 00015482146030 All serial numbers

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated