www.mhlw.go.jp/stf/newpage_22220.html
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自主回収｜クラス２｜報道発表資料｜厚生労働省
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https://www.mhlw.go.jp/stf/newpage_22220.html
About this page
This page announces a Class II voluntary recall of an in vitro diagnostic device "QuickNavi™-COVID19 Ag" (antigen rapid test kit) manufactured by Denka Co., Ltd., issued by the Ministry of Health, Labour and Welfare on November 15, 2021. Following ongoing investigations, the company confirmed signs of increased false positive rates over time in certain batches of 8-minute test products, expanding the recall scope. The recall covers 91,700 boxes (917,000 units) distributed between July 5 and August 3, 2021. Of these, 613,860 units were previously distributed through a distribution program. Denka will replace them with new products at its own expense.
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