Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00340-1
Product Name/Description Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)

Catalogue Number: DF107
Lot Numbers: GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267, FB3267
ARTG Number: 182779
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 17/04/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.
Contact Information 1800 310 300 - Siemens Technical Support Centre