Generic Name: Human Red Blood Cell Solution Trade Name: Irradiated Red Blood Cell Solution-lr "japanese Red Cross"

Recalling firm
Name of Manufacturer/Distributor: Japanese Red Cross Society Address of Manufacturer/Distributor: Japanese Red Cross Society Annex, 1-2-1 Shibakoen, Minato-ku, Tokyo Type of License: Class I...
Product
Lot: 対象ロット: 54‐1126‐8906 数量 : 400mL由来 1本 出荷時期 : 令和8年2月16日. Use: 血中赤血球不足又はその機能廃絶に適する。. Health hazards: 当該血液製剤は、患者に使用されていないため、健康被害はありません。
Reason
In accordance with the procedures for handling post-donation information, we investigated a donor who was notified that an infection caused by a pathogen had been confirmed following their donation. Since the blood products manufactured from the donated blood had not yet been used, we have decided to retrieve and recall those blood products from the medical institution.
Classification
Class I
Category
drug recall
Country
Japan
Agency
PMDA-DRUG
Recall date
2026-02-27
Status
Ongoing

Official recall notice from PMDA-DRUG

Recall details on Nibble Recalls: https://trynibble.app/recalls/1c2af5f7-5b47-4ee6-baf0-f6f7401febb7