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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00778-1
Product Name/Description	ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD)) ADVIA Centaur Folate (100 tests) Kit Lot Numbers: 22288218, 22296218 & 22907218 ADVIA Centaur Folate (500 tests) Kit Lot Numbers: 22289218, 22297218 & 22535218 ADVIA Centaur Folate (500 tests) Kit Lot Number: 22298218 ADVIA Centaur Folate (2500 tests) Kit Lot Number: 22299218 Expiration Date: 17 Feb 2014 ARTG Number:175700
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/07/2013
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens has confirmed that a portion of Folate ReadyPacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (QC) and patient results. If the calibration and QC on a ReadyPack are valid, results generated with this ReadyPack are not affected. However, due to the sporadic nature of the issue, successful calibration and QC on one ReadyPack may not reflect acceptable performance of other ReadyPacks in the lot.
Recall Action	Recall for Product Correction
Recall Action Instructions	If a customer has an alternative method or lot of ADVIA Centaur Folate, Siemens Healthcare is advising users to transition all folate testing to the alternative lot or method. Siemens Healthcare is providing users with work around instructions to follow with the affected product. The Laboratory Medical Director should determine if repeat testing of patient samples that demonstrated results below the reference interval is appropriate.
Contact Information	1800 310 300 - Siemens Technical Support Centre