Recall Z-2014-2021
Siemens Healthcare Diagnostics, Inc. · initiated May 18, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Software version: 1.4 or lower UDI - 00630414595467
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
FDA-determined cause: Software design
Action taken
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
Details
- Recall number
- Z-2014-2021
- Initiated
- May 18, 2021
- Terminated
- August 30, 2024
- Product code
- JGS – Electrode, Ion Specific, Sodium
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY