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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01514-1
Product Name/Description	DuraClone B27 Reagent Kit - an in vitro diagnostic medical device (IVD) Ref Number: B36862 Multiple Lot Numbers ARTG Number: 224373
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/12/2017
Responsible Entity	Beckman Coulter Australia Pty Ltd
Reason/Issue	As a result of internal investigations, Beckman Coulter has determined that certain DuraClone B27 reagent kits have a defect that may generate false negative results in some samples. This defect is most likely to affect samples with MFI values between 10 to 19 when tested on Navios/Cytomics FC 500 cytometers and channel values between 517 to 602 when tested on BD FACSCalibur/ BC FACScan cytometers. There has been no report of death or injury related to this defect.
Recall Action	Recall
Recall Action Instructions	Beckman Coulter is advising users to run tests of lot numbers 050917, 070417_11, 090517, 120617_02, 170417_09, 170417_11, 170417_11, 190617 and 240717 with the new determinant and indeterminant zone values provided with the Customer Letter. Other affected lot numbers should be disposed of in an appropriate manner. Affected customers may contact their local Beckman Coulter representative for replacement product. Beckman Coulter recommends if required, redetermination of those results obtained for the above specified 8 lot numbers using the new determinant values outlined in the Customer Letter. For all lot numbers, Beckman Coulter recommend samples previously reported as ‘negative’ to be verified using alternate methods such as PCR if considered necessary. This action has been closed out on the 22/11/2018.
Contact Information	1800 060 881 - Customer Support Centre