自主回収 against Denka Company Limited

デンカ株式会社 (医薬品医療機器等法)
医薬品医療機器等法Ministry of Health, Labour and WelfareConfirmed entity match15 November 2021
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/api/v1/enforcements?corporate_number=3010001008757&limit=10

Action summary

Company
Original: デンカ株式会社
Corporate Number: 3010001008757
Entity match
Confirmed entity match95/100Machine extracted
Normalized Japanese name matched to a company profile with Corporate Number
Matched by normalized Japanese company name to an enriched company profile with a Corporate Number.
Governing law
医薬品医療機器等法
医薬品医療機器等法
Action type
自主回収
自主回収
Action date
15 November 2021
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省

Violation

Machine-translated summary — verify against original

Because signs of increased false positive rates over time were confirmed in some lots of the antigen rapid test kits, the company conducted a voluntary recall of the affected products.

Show original Japanese text

抗原簡易キットの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、対象製品の自主回収を行った。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under 医薬品医療機器等法.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare announcement (Japanese)Archived source snapshot
Extracted at
2026-04-25T00:20:21.136+00:00
Evidence checked
2026-04-25T00:20:21.136+00:00
Archive captured
2026-04-09T18:02:32.503+00:00
Show audit JSON
{
  "record": {
    "id": "8ce3f95f-1f04-4f01-9831-f47c6957fe29",
    "url": "https://regbase.jp/en/enforcement/other-denka-20211115",
    "company_name_original": "デンカ株式会社",
    "company_name_registry": "デンカ株式会社",
    "corporate_number": "3010001008757",
    "law": {
      "ja": "医薬品医療機器等法",
      "en": "医薬品医療機器等法"
    },
    "action_type": {
      "ja": "自主回収",
      "en": "自主回収"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "confirmed",
    "confidence": 95,
    "method": "normalized_name_with_corporate_number",
    "method_label": "Normalized Japanese name matched to a company profile with Corporate Number",
    "notes": "Matched by normalized Japanese company name to an enriched company profile with a Corporate Number."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 医薬品医療機器等法."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-denka-20211115",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_22220.html",
    "archiveUrl": "https://kiroku.today/view/a66c6aa6d3rsbexz",
    "archiveCapturedAt": "2026-04-09T18:02:32.503+00:00",
    "extractedAt": "2026-04-25T00:20:21.136+00:00",
    "translatedAt": "2026-05-01T07:08:43.171+00:00",
    "evidenceCheckedAt": "2026-04-25T00:20:21.136+00:00",
    "generatedAt": "2026-06-19T13:16:02.246Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

Company info

English name
Denka Company Limited Official
Japanese name
デンカ株式会社
Corporate Number
3010001008757
Registered address
東京都中央区日本橋室町2丁目1番1号
See company profile →

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.