Generic Name: Rubella Virus Antibody Kit Trade Name: R-hi "seiken
Recall Summary Denka Corporation is recalling R-HI "Seiken" rubella virus antibody test kits (Lot 745041, expiration April 2026) because the products did not meet performance standards by their expiration date. The kits are used to measure rubella virus antibody levels in laboratory testing. If used, the test would not produce valid results, which could lead to inconclusive test outcomes rather than misdiagnosis, and no health injuries have been reported so far.
- Recalling firm
- Name of manufacturer and distributor: DENKA CORPORATION Location of manufacturer and distributor: 1359-1, Kagamida, Kigetsu, Gosen-shi, Niigata Prefecture Type of license: In vitro diagnostic...
- Product
- Lot: ２％固定一日齢ヒヨコ赤血球液 ロット番号： 745041 使用期限 ： 2026年4月 出荷数量 ： 18箱 出荷時期 ： 2025年7月7日～2025年7月29日. Use: 風疹ウイルスＨＩ抗体価の測定. Health hazards: 回収対象の製品を使用した場合、ＨＩ抗体価試験が不成立となるため、誤診断に繋がることはなく、重篤な健康 被害は発生しないものと考えます。なお、現在までに当該事象に伴う健康被害の報告はありません。
- Reason
- The products in the lots subject to recall are being voluntarily recalled because it was found that the product performance did not meet the standards by the expiration date.
- Classification
- Class II
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Recall date
- 2026-04-17
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/4e871c2b-a557-41ef-9632-ff5f7fb83506