Generic Name: Platelet Aggregation Assay Kit — Trade Name: Verifynow Pru Test
- Recalling firm
- Name of Manufacturer and Distributor: I.L. Japan Co., Ltd. — Address of Manufacturer and Distributor: 1-3-30 Mita, Minato-ku, Tokyo — Type of License: Manufacturer and Distributor of In Vitro...
- Product
- Lot: 対象ロット：WP1559 出荷数量：78 kit 出荷時期：2025年6月18日〜2025年8月13日. Use: 血小板凝集能の測定. Health hazards: 上記の通り、混入品を使用された場合に診断の遅延が予想されますが、測定結果自体への影響は無いため、重篤 な健康被害の可能性は無いと考えられます。これまでのところ、本邦では本事象に該当すると考えられる報告は 確認されておりません。
- Reason
- According to the results of the latest internal investigation by the manufacturer, Accriva Diagnostics, Inc., it has been determined that the above-mentioned affected products may have been contaminated with a different product of similar appearance, the “VerifyNow P2Y12 Test Device,” which is distributed in Japan as a research reagent. Although the information for the affected product is printed on the direct packaging of all reagent cartridges, there is a possibility that a small number of cartridges may contain a different product labeled “VerifyNow P2Y12” on the cartridge itself...
- Classification
- Class II
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/0f086961-dd45-44e6-a5c8-4829c1e8544b