Z-2014-2021Class II

The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical...

Name: Z-2014-2021 The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-05-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-05-18 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum... on 2021-05-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2014-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-18
Posted: 2021-07-06
Terminated: 2024-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: Siemes issued an Urgent Medical Device Correction (UMDC) was mailed to all US affected customers by FedEx beginning on 05/18/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 05/18/2021. Letter states reason for recall, health risk, and action to take: Until the next version of instrument software is available Siemens recommends changing the software behavior from the current default of 2: Warning+STOP to 1: Warning. The behavior for the Warning setting is to display the test result as ERROR with a Safety(S) flag and generate a yellow warning in the Operators event log for each test result encountering a mix error. The instrument will continue to process samples. The flagged test must be repeated to obtain a valid result. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. The ADVIA Chemistry XPT version 1.6 software will be released in June 2021
Quantity in commerce: 842 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, MA, MD, MI, MN, NY, OH, PA, TX and the countries of Australia, Bahrain, Brazil, Canada, Chile, Croatia, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Portugal, Republic Korea, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Vietnam.
Product codes and lots: Software version: 1.4 or lower UDI - 00630414595467

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2014-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2014-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-06

Product code JGS

K990346Class IIBayer Advia 1650 Chemistry SystemBayer Corp. / cleared 1999-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)