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Terminated

AUTION HYBRID AU-4050

FDA Recall Z-1850-2019 · Posted None

Recalling FirmArkray Factory USA, Inc.
Recall StatusTerminated
Product CodeKQO
Date Initiated2019-05-03
Date Terminated2020-09-17
Product Quantity159 units

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.

Firm Action

The firm initiated the field correction by email on 05/03/2019. The letter stated how to recognize a product failure and the actions to be taking by the customer until the software upgrade is ready for installation.

Root Cause

Software design

Distribution Pattern

US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc. · 2013-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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