{"data":[{"id":"8ce3f95f-1f04-4f01-9831-f47c6957fe29","company_name":"デンカ株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["自主回収"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"自主回収","action_date":"2021-11-15","announcement_date":"2026-04-09","violation_summary":"新潟県より、別添のとおり、デンカ株式会社が下記の体外診断用医薬品（抗原簡易キット）の自主回収に着手した旨の情報提供がなされましたので、お知らせいたします。本製品については、11月８日より15分で判定する製品の一部ロットを対象に自主回収が行われていますが、デンカ株式会社が継続的な調査を実施したところ、８分で判定する製品についても、一部ロットにおいて時間の経過とともに偽陽性率が高まる兆候が確認されたため、以下の製品まで対象を拡大し自主回収が行われるものです。","violation_summary_en":"Denkai Corporation has initiated a voluntary recall of certain lots of its in vitro diagnostic medical device (antigen rapid test kit) following reports from Niigata Prefecture. Initially, a recall was conducted for some lots of products that provide results in 15 minutes starting from November 8. After ongoing investigation, it was found that for some lots of products that provide results in 8 minutes, the false positive rate increased over time. As a result, the recall has been expanded to include additional products.","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_22220.html","url":"https://regbase.jp/enforcement/other-denka-20211115"},{"id":"e30cfd89-3c25-47cb-8453-bfafe7a20778","company_name":"デンカ株式会社","company_name_en":null,"corporate_number":null,"authority":"厚生労働省","authorities":["厚生労働省"],"authority_count":1,"action_types":["自主回収"],"regional_record_count":1,"source_document_count":1,"law_name":"医薬品医療機器等法","action_type":"自主回収","action_date":"2021-11-08","announcement_date":"2026-04-10","violation_summary":"新潟県より、別添のとおり、デンカ株式会社が下記の体外診断用医薬品（抗原簡易キット）の自主回収に着手した旨の情報提供がなされましたので、お知らせいたします。","violation_summary_en":"Niigata Prefecture has provided information that Denka Corporation has initiated a voluntary recall of the following in vitro diagnostic medical device (antigen rapid test kit).","penalty_amount":null,"is_verified":false,"record_verified":false,"entity_match":{"status":"unresolved","confidence":85,"method":"nta_strict_name_nationally_unique","notes":"A current-policy Corporate Number match to a verified company profile is not available."},"human_review_status":"unreviewed","source_url":"https://www.mhlw.go.jp/stf/newpage_22115.html","url":"https://regbase.jp/enforcement/other-denka-20211108"}],"meta":{"query":"デンカ株式会社","corporate_number":null,"law":null,"authority":null,"action_type":null,"count":2,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":9,"reset_at":"2026-08-04T18:47:32.147Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":56,"reset_at":"2026-08-05T18:46:32.147Z"}}}