Beckman Coulter Mishima K.K recall: Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480…
Beckman Coulter Mishima K.K. is recalling Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480… – 492 units. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on August 3, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480… |
| Brand | Beckman Coulter Mishima K.K |
| Company | Beckman Coulter Mishima K.K. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 3, 2026 |
| Published by FDA | October 7, 2026 |
| Quantity | 492 units |
| Recall ID | 99588 |
Recalled products
- Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965 B96693 / 14987666542972 B12183 / 14987666540671 The AU480 Chemistry Analyzer measure analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material, and other accessories. This system is for in vitro diagnostic use only.
- FDA recall number
- Z-3332-2026
- Codes, lots and dates
- Products containing affected software: Item Numbers / UDI-DI codes: Item Number: B96692 UDI-DI code: 14987666542965 Item Number: B96693 UDI-DI code: 14987666542972 Item Number: B12183 UDI-DI code: 14987666540671 Item Number: N3151400 UDI-DI code: Due to the age of the device and the fact that it has exceeded its storage period, the UDI number is not available.)
- Quantity
- 492 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99588
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Sunto-Gun, Japan
Why it was recalled
The reason the FDA lists: “Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA, GU, HI, IA, IL, IN, KS, KY, MN, MO, NC, NM, NY, OK, PA, SD, TX, and WI. The countries of Algeria, Australia, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Cyprus, Czechia, Egypt, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Malaysia, Morocco, Myanmar, Nepal, Nigeria, Pakistan, Poland, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, South Africa, Taiwan, Province of China, Turkey, United Arab Emirates, and Viet Nam.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99588, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Beckman Coulter Mishima K.K Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480… recalled?
Yes. Beckman Coulter Mishima K.K. recalled it on August 3, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.