medical Class II Updated 2021-07-14

Siemens Healthcare Diagnostics, Inc. recalls The ADVIA Chemistry XPT Chemistry System, Siemens Material N

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software version: 1.4 or lower UDI - 00630414595467
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →