| Class 2 Device Recall Siemens | |
Date Initiated by Firm | May 18, 2021 |
Create Date | July 06, 2021 |
Recall Status1 |
Terminated 3 on August 30, 2024 |
Recall Number | Z-2014-2021 |
Recall Event ID |
88086 |
510(K)Number | K990346 |
Product Classification |
Electrode, ion specific, sodium - Product Code JGS
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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. |
Code Information |
Software version: 1.4 or lower
UDI - 00630414595467 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | SAME 914-631-8000 |
Manufacturer 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 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JGS
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