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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00933-1
Product Name/Description ADVIA 1200, 1650, 1800 and 2400 Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD)

Siemens Reference Number: CHSW 13-01

ARTG Number: 174383
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 5/09/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens has confirmed that the affected ADVIA Chemistry Systems will report results calculated using the Ratio Parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. In cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. If a numerical result is generated with a flag, the ratio will be reported without a flag.
Recall Action Recall for Product Correction
Recall Action Instructions End users are requested to ensure that all ratio tests should be reviewed for flags prior to approving. Siemen's is developing a new version of software that will introduce a new flag for all ratio results that have a flag on a component test.
Contact Information 1800 310 300 - Siemens Technical Support Center