Medical device manufacturer, Radiometer, has issued a medical device safety alert concerning its NT-proBNP Test Kits, [942-930 Lot 13956]
The manufacturer has become aware that the Date of Manufacturing printed on some of the box labels of the affected products is incorrect. The Lot is manufactured in January 2018 and should be labeled "2018-01". Some of the boxes are incorrectly labeled "2018-06".
The NT-proBNP Test Kits includes a second box label including a barcode which when scanned will display the correct Date of Manufacturing, "2018-01", on the analyzer. Furthermore, this second box label shows the correct Expiration Date, which is December 2018, "2018-12".
According to the manufacturer, the Field Action relates to China since the incorrect Date of Manufacturing is printed on a China specific label. There is no risk for the patient due to the fact that the problem described does not affect the product itself and due to the fact that the expiration Date is printed correctly. For this reason the customer may continue to use the product.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 21 May 2018.