Retiro De Equipo (Recall) de Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)

Recall

RC-2013-RN-00340-1

Class I

2013-04-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00340-1

Siemens has confirmed that the tacr method may demonstrate reduced on-board stability which may result in imprecise and inaccurate qc and patient results. investigations have shown that results may become imprecise when tacr flexes are stored on-board the instrument for 2 days or more. this imprecision typically presents as one or more elevated tacr results following a period of instrument inactivity. subsequent results from the same well may exhibit depressed values. the discordant high results may be elevated by as much as 2 times the expected value and the discordant low results may be depressed by as much as fifty percent. longer periods of on-board storage (> 2 days) coupled with periods of instrument standby may increase the magnitude of elevated and depressed results.

Siemens is asking customers to discard the remaining inventory of the affected stock. Also, Siemens is recommending discussing the issues with the laboratory director to determine if additional follow up is appropriate for TACR results reported in the laboratory. Beginning with TACR reagent cartridge lot BB4087, an “Alert Card” indicating that the on-board stability is limited to 8 hours, will be packaged with in the TACR cartons.