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

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-OTHER-ABOTUTOZIYA-202608041528
Generated at: 5 August 2026 at 00:28
Record URL: https://regbase.jp/en/enforcement/other-abotutoziyapan-20230303

1. Review Summary

Disclosure name	アボットジャパン合同会社	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	3 March 2023	Authority	Ministry of Health, Labour and Welfare
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）	Action type	Voluntary Recall
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	アボットジャパン合同会社

3. Enforcement Record

Target name in disclosure	アボットジャパン合同会社
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	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） / Voluntary Recall
Action / announcement date	Action: 3 March 2023 / Announcement: 2 April 2026
English summary	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.
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
Official source	https://www.mhlw.go.jp/stf/newpage_31609.html
Source archive	https://kiroku.today/a/db712f55cfhf0inj
Extraction / evidence timestamps	Extracted: 25 April 2026 at 08:37 / Evidence checked: 25 April 2026 at 08:37 / Archive captured: 12 July 2026 at 15:34

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

Current page: Enforcement record

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

Free report

Save the disclosure record naming アボットジャパン合同会社

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for アボットジャパン合同会社

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E3%82%A2%E3%83%9C%E3%83%83%E3%83%88%E3%82%B8%E3%83%A3%E3%83%91%E3%83%B3%E5%90%88%E5%90%8C%E4%BC%9A%E7%A4%BE&limit=10

Open JSON Specs

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.

Evidence pack

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": "2026-08-04T15:28:19.273Z"
  },
  "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.