PMDA Class I recall notice: Japanese Red Cross fresh frozen plasma and platelet products
クラスI回収 該当回収品目 新鮮凍結血漿-LR「日赤」240、照射濃厚血小板-LRBS「日赤」
Published: 2026-08-12 · Source: Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates · Stage: Government Announcement · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-08-13
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
The Pharmaceuticals and Medical Devices Agency (PMDA) safety updates page lists a Class I recall notice dated 2026-08-12. Based on the title, the affected items are Fresh Frozen Plasma-LR 'Nisseki' 240 and Irradiated Platelet Concentrate-LR (BS) 'Nisseki', which appear to be blood products from the Japanese Red Cross Society. The provided metadata does not state the reason for the recall, affected lots, quantities, or required actions.
Business Impact
Hospitals, blood centers, and organizations handling these blood products may be affected if they hold or distribute the listed items. Class I is generally the most serious recall category in Japan, so the notice could warrant prompt attention, though specifics are not provided here.
Recommended Action
Review the official PMDA Japanese notice to confirm the affected products, lots, recall reason, and any instructions before taking any action.