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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00050-1
Product Name/Description Dimension Tacrolimus (TACR) Flex Reagent Cartridge, An in vitro diagnostic medical device (IVD)

Catalogue number: DF107 (SMN10444938)

Lot number: FA3316

ARTG 182779
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 18/01/2013
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue The manufacturer has confirmed customer complaints of low patient sample recovery with TACR Flex, lot FA3316. Quality Control materials have not exhibited low recovery of the same magnitude.
Recall Action Recall
Recall Action Instructions Siemens is requesting customers to immediately discard any remaining Dimension TACR (DF107) Flex lot FA3316. Laboratory Directors are also being advised to review patient tests to determine if follow-up testing is required.
Contact Information 1800 310 300 - Siemens Technical Support Centre