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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