FDA recall Z-1850-2019

Arkray Factory USA, Inc. · Class II · device

Product

AUTION HYBRID AU-4050

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

Key facts

Status: Terminated
Initiation date: 2019-05-03
Report date: 2019-06-26
Termination date: 2020-09-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2019