Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00250-1
Product Name/Description	WIZARD2 Gamma Counters. An in vitro diagnostic medical device (IVD) WIZARD2 1-detector, 550 samples Catalogue Number: 2470-0010 WIZARD2 2-detector, 550 Catalogue Number: 2470-0020 WIZARD2 5-detector, 550 Catalogue Number: 2470-0050 WIZARD2 1-detector, 3",1000 Catalogue Number: 2480-0010 Multiple Serial Numbers affected ARTG Number: 209297
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/03/2016
Responsible Entity	PerkinElmer
Reason/Issue	This is a follow up to a previous recall in 2015 (TGA Ref: RC-2015-RN-00417-1). It has been identified that the affected barcodes were distributed from February 2010, not June 2012 as originally understood. PerkinElmer have become aware that the content of the second of the two #023 barcode ID labels provided on each page of the Barcode ID Label Binder are incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. In the event measurement protocols have been programmed for both ID #023 and #024, and the WIZARD2 Gamma Counter scans the affected barcode label, the protocol associated with barcode ID #024 is executed. If the error is undetected, the WIZARD2 Gamma Counter may produce erroneous results. The issue will lead to a delay in reporting results due to the delay to resolve the issue and retest the samples or test new samples. Dependent on individual patient clinical status an incorrect result may impact disease progression or renal function.
Recall Action	Recall for Product Correction
Recall Action Instructions	Users are advised to ensure that they remove the barcode labels ID #023 from all barcode label binders in their possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided to affected customers. This action has been closed-out on 18/05/2017.
Contact Information	03 9212 8522 - PerkinElmer