- Recalling firm
- Beckman Coulter Mishima K.K.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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.)
- Units affected
- 492 units
- Distribution pattern
- 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.
- Firm location
- Sunto-Gun, Japan
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3332-2026
- Recall initiated
- August 3, 2026
- FDA classification date
- September 30, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99588
- Last updated on HTM Vibe
- October 13, 2026
