PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 14, 2021 Initiated: May 18, 2021 #Z-2014-2021

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.

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

Details

Units Affected
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.
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 842 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2014-2021.

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