Product Defects and Health Damage Caused by Cell Processing
First written in FY2024. 1 of 3 entries say "Restated". Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026MaterialisedAnnual report
「In August 2025, following the occurrence of a death suspected to be related to certain cell-processed products and other products manufactured by the Company (the “Products”), the Company received administrative action under the Act on Ensuring the Safety of Regenerative Medicine, etc.」
It states that, regarding the risk of health damage caused by cell processing, a death suspected to be related to a product and administrative action have actually occurred. However, a causal relationship has not been confirmed at this time. - FY2025RestatedAnnual report
「However, there is no guarantee that unforeseen quality problems, such as contamination or the inclusion of foreign matter, will not occur in any product, and the Group may take measures such as accepting returns or conducting recalls.」
The possibility of product defects and health damage caused by cell processing continues to be disclosed. - FY2024First statedAnnual report
「There is no guarantee that unforeseen quality problems, such as contamination or the inclusion of foreign matter, will not occur in any product, and the Group may take measures such as accepting returns or conducting recalls.」
It identifies GMP-compliant quality control, raw-material selection and product liability insurance as measures.