After shipment, stability test performed on the kit lot has shown that the kit functions as expected and hence the kit can be used through-out the original shelf-life.Therefore, the matter is deemed to not affect patient safety.Since the kit lot was already shipped with the shorter shelf-life, this expiry date must be adhered to, but since the new date is not stated on the alert sticker and the original kit box label remained on the kit box stating the original expiration date, it could be considered misbranding which is the reason for the recall.The recall decision was taken by the quality review board 2017-05-22.All affected countries regulatory authorities, as well as all affected euro diagnostica customers, have been notified of the recall.A field safety notice was sent out.The extent of the problem is presently deemed to be only fana200 ts 3577.
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