Generic Name: Activated Partial Thromboplastin Time Kit (*) — Brand Name: Hemus Il Synsapex Aptt
- Recalling firm
- Name of Manufacturer/Distributor: I.L. Japan Co., Ltd. — Address of Manufacturer/Distributor: 1-3-30 Mita, Minato-ku, Tokyo — Type of License: Manufacturer/Distributor of In Vitro Diagnostic...
- Product
- Lot: 製品番号：00020007400 対象ロット：N0542231 出荷数量：15 kit 出荷時期：2025年4月16日〜2025年11月4日. Use: 血漿中の活性化部分トロンボプラスチン時間の測定. Health hazards: 上記の通り、対象品は本来の濃度の二倍の防腐剤を含んでおりますが、測定結果に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、本邦では本事象に起因して発生したと考えられる報告は 確認されておりません。
- Reason
- According to the latest internal investigation conducted by the manufacturer, Instrumentation Laboratories, Inc., it has been determined that the concentration of preservatives in the affected products listed above was twice the specified level. Although the manufacturer’s verification has confirmed that this does not affect product performance or measurement results, we are conducting a voluntary recall of the affected products because they do not meet the manufacturer’s standards.
- 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/fe655ab3-8290-4c7e-9388-f1e4275b582f