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The ADVIA Chemistry XPT Chemistry System, Siemens Material… recallZ-2014-2021 · Siemens Healthcare Diagnostics, Inc. · initiated May 18, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-2014-2021
Status
Terminated
Initiated by the company
May 18, 2021
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
842 units
Product code
JGS
FDA submissions
K990346
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 description

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 (models, lots, serial numbers)

Software version: 1.4 or lower UDI - 00630414595467

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K990346 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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