Beckman Coulter Mishima K.K. recalls
Every recall we track for Beckman Coulter Mishima K.K. — 7 in all, from 2024–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
7 recalls since 2017.
All FDA recall records for Beckman Coulter Mishima K.K. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 2 | 0 | 2 |
| 2026 (to date) | 0 | 2 | 1 | 0 | 3 |
What to do if you have a recalled Beckman Coulter Mishima K.K. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Beckman Coulter Mishima K.K. recalls
5 shown- Lower riskMedical device
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 /
Beckman Coulter recalls 492 AU480 Chemistry Analyzers with specific UDI-DI codes that may show a system error message, delaying patient results. Affected units include those with Windows 10 IoT Enterprise 2021 LTSC PCs and Microsoft SQL Server 2022 Express software.
Beckman CoulterAug 3, 2026 - Use cautionMedical device
Beckman Coulter Mishima K.K. recalls CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Beckman Coulter recalls AU5800 chemistry analyzers with specific serial numbers that may cause delays in results due to software errors after 15 minutes of calibration monitor use. Affected units require service to fix.
Beckman CoulterJan 30, 2026 - Lower riskMedical device
Beckman Coulter Mishima K.K. recalls Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot
Beckman Coulter recalls sample probes with defective tips that mix cleaning water and sample, causing inaccurate test results. Affected units sold between specific dates and serial numbers.
Beckman CoulterApr 30, 2025 - Lower riskMedical device
Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers (REF C63520) due to software issues that may cause delayed results after processing 250 racks. Affected units have specific serial numbers.
Beckman CoulterJul 10, 2024 - Lower riskMedical device
Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in
Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with software bugs that could cause incorrect patient test results. No immediate action is needed but users should check for specific serial numbers.
Beckman CoulterJun 5, 2024
Beckman Coulter Mishima K.K. recall questions
How many recalls has Beckman Coulter Mishima K.K. had?
7 recalls from Beckman Coulter Mishima K.K. are on record with U.S. safety agencies, from 2024–2026.
What is the most recent Beckman Coulter Mishima K.K. recall?
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 /, dated Aug 3, 2026. Every Beckman Coulter Mishima K.K. recall is listed on this page, newest first.
What should I do if I have a recalled Beckman Coulter Mishima K.K. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Beckman Coulter Mishima K.K. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.