Enforcement record

Voluntary Recall disclosure naming アボットジャパン合同会社

アボットジャパン合同会社 (医療機器の自主回収に関する規定（行政指導・自主回収の実施）)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

医療機器の自主回収に関する規定（行政指導・自主回収の実施）Ministry of Health, Labour and WelfareGovernment disclosure3 March 2023

Action type

Voluntary Recall

Law

医療機器の自主回収に関する規定（行政指導・自主回収の実施）

Authority

Ministry of Health, Labour and Welfare

Action date

3 March 2023

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority: Ministry of Health, Labour and Welfare
Official source URL: Recorded by RegBase
Entity match: Not confirmed; shown under the published name
Kiroku preservation: Completed archive verified; Captured: Jul 12, 2026, 03:34 PM JST

“Confirmed” means that RegBase matched this record to the cited public disclosure or entity under the stated checks. It does not verify the truth of the disclosure or guarantee the entity’s current status, creditworthiness, or any legal conclusion.

Open the official source links in the section below to review the original disclosure.

Action summary

Company: アボットジャパン合同会社Japanese only
Original: アボットジャパン合同会社
Governing law: 医療機器の自主回収に関する規定（行政指導・自主回収の実施）
医療機器の自主回収に関する規定（行政指導・自主回収の実施）
Action type: Voluntary Recall
自主回収
Action date: 3 March 2023
Issuing authority: Ministry of Health, Labour and Welfare
厚生労働省
Industry context: 医療機器

Violation

Machine-translated summary — verify against original

Product name: FreeStyle Libre, quantity subject to recall: 7,604 units (package lot 6916030: 4,226 units, 6916031: 3,378 units), shipment period: from October 19, 2022, to November 15, 2022.

Show original Japanese text

販売名：FreeStyleリブレ、回収対象数量：7,604個（パッケージロット 6916030:4,226個、6916031:3,378個）、出荷時期：令和４年10月19日から令和４年11月15日

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 医療機器の自主回収に関する規定（行政指導・自主回収の実施）.

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.

Open original sources and verification detailsOfficial URL, direct PDF, and Kiroku archive

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack

Extracted at: 2026-04-24T23:37:32.651+00:00
Evidence checked: 2026-04-24T23:37:32.651+00:00
Archive captured: 2026-07-12T06:34:31.010763+00:00

Show audit JSON

{
  "record": {
    "id": "3a8ad271-aaec-4d72-af4d-7fd0ae0c8044",
    "url": "https://regbase.jp/en/enforcement/other-abotutoziyapan-20230303",
    "company_name_original": "アボットジャパン合同会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医療機器の自主回収に関する規定（行政指導・自主回収の実施）",
      "en": "医療機器の自主回収に関する規定（行政指導・自主回収の実施）"
    },
    "action_type": {
      "ja": "自主回収",
      "en": "Voluntary Recall"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (アボットジャパン合同会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "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 医療機器の自主回収に関する規定（行政指導・自主回収の実施）."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-abotutoziyapan-20230303",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_31609.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/db712f55cfhf0inj",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_31609.html",
    "archiveCapturedAt": "2026-07-12T06:34:31.010763+00:00",
    "extractedAt": "2026-04-24T23:37:32.651+00:00",
    "translatedAt": "2026-05-01T06:51:44.782+00:00",
    "evidenceCheckedAt": "2026-04-24T23:37:32.651+00:00",
    "generatedAt": "2026-09-18T20:02:11.111Z"
  },
  "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.

Language

日本語版を見る (Japanese)

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