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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00417-1
Product Name/Description	WIZARD2 Gamma Counters WIZARD2 1-detector, 550 samples 2470-0010 Serial Numbers (SN):DG07129377, SGWZ33130034, SGWZ45130065, SGWZ32140180 WIZARD2 2-detector, 550 2470-0020 SN:DG12120038, SGWZ39130048 WIZARD2 5-detector, 550 2470-0050 SN:SGWZ30140174, SGWZ46140216 WIZARD2 5-detector, 1000 2470-0150 SN:SGWZ36130042 WIZARD2 1-detector, 3",1000 2480-0010 SN:DG10129717, DG03130240, SGWZ20130008, SGWZ23130015, SGWZ45130066, SGWZ08140110, SGWZ08140111 ARTG number: 209297
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/05/2015
Responsible Entity	PerkinElmer
Reason/Issue	PerkinElmer have become aware through a customer complaint 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 impact on health is dependent on the clinical application in which the WIZARD2 Gamma Counter is being used. 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 08/08/2016.
Contact Information	03 9212 8500 - PerkinElmer