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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00859-1
Product Name/Description	Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD). Reference Number: B13129 Lot Number: 689202 Expiry date: 16 September 2017 ARTG Number: 213976
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	29/06/2016
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	Beckman Coulter has identified that the Quality Control (QC) value card includes incorrect standard deviation values for the Access AMH QC Kit, lot 689202. The QC value card for this lot lists the following standard deviation values: QC1 as 0.02, QC2 as 0.11 and QC3 as 0.65. The correct standard deviation values are as follows: QC1 is 0.15, QC2 is 0.76 and QC3 is 2.30. Use of this restrictive QC range may result in QC failures but there is no impact to patient results.
Recall Action	Recall for Product Correction
Recall Action Instructions	Beckman Coulter is advising users to use the correct QC values, as provided, when establishing QC ranges for the affected lot. Users should also confirm that the Access AMH QC assigned mean and standard deviation values are set appropriately per individual laboratory procedures. This action has been closed-out on 20/02/2017.
Contact Information	1800 060 881 - Beckman Coulter Technical Support Centre