FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: 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
- 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.
- Status
- Terminated
- Initiated
- 2021-05-18
- Posted
- not on file
- Terminated
- 2024-08-30
- 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
- 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
- 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.
- Lot, serial or model codes
- Software version: 1.4 or lower UDI - 00630414595467
- 510(k) numbers
- ["K990346"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28