Recall Z-1850-2019— Arkray Factory USA, Inc.

Name: FDA recall Z-1850-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-03

Class II · Terminated

Class II FDA medical device recall by Arkray Factory USA, Inc., initiated 2019-05-03, terminated 2020-09-17. It names one FDA 510(k) clearance: K121456. Product: AUTION HYBRID AU-4050. Reason: 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..

Recalling firm: Arkray Factory USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Terminated: 2020-09-17
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.·cleared 2013-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.