PMDA Class I recall notice: Fresh Frozen Plasma-LR "Nissekis" 480
クラスI回収 該当回収品目 新鮮凍結血漿-LR「日赤」480
Published: 2026-10-05 · Source: Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates · Stage: Government Announcement · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-10-06
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 information page lists a Class I recall entry for the product "Fresh Frozen Plasma-LR 'Nisseki' 480" (Japanese Red Cross), published 2026-10-05. The provided metadata contains only the title and a generic PMDA safety-update description, so the reason for the recall, affected lots, and scope are not stated.
Business Impact
Healthcare providers, medical institutions, or distributors handling this blood product may be affected, as Class I is generally the most serious recall category. The actual impact cannot be determined from the provided metadata.
Recommended Action
Review the official PMDA recall page in Japanese to confirm the recall reason, affected lots, and any instructions before relying on this summary.