Recall – Eroneous patient result without alert from clinical chemistry analyzer

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report: 7/14/2021
Class II

PRODUCT

The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.

Recall Number: Z-2014-2021

REASON

ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may not be aligned with customer expectations for the current default mixer failure detection setting of 2; an erroneously elevated or depressed patient result to be reported without alert on the test result.

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc. on 5/18/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

842 units

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

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