Z-2014-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- May 18, 2021
- Termination Date
- August 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 842 units
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
Distribution Pattern
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.
Code Information
Software version: 1.4 or lower UDI - 00630414595467