Health Canada — Medical Devices · Canada · 2015-07-09 · Type III
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Reported risk: Manufacturer has 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.
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