Beckman Coulter Chemistry Analyzer AU480
When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Beckman Coulter Mishima K.K. is recalling certain AU480 chemistry analyzers, systems/units containing affected software/SQL, because the instrument software may not start.
The analyzers, which measure analytes in samples for in vitro diagnostic use, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the software on PCs pre-installed with Microsoft SQL Server 2022 Express. This causes a delay in obtaining patient results. The recall began August 3, 2026, and the FDA classified it September 30, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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.
- UDI-DI
- 14987666542965
- 14987666542972
- 14987666540671
Details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution in the states of Arkansas, California, Delaware, Florida, Georgia, GU, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Minnesota, Missouri, North Carolina, New Mexico, New York, Oklahoma, Pennsylvania, South Dakota, Texas, and Wisconsin. 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.
- Event ID
- 99588
- Recall No.
- Z-3332-2026
- Company
- Beckman Coulter Mishima K.K.Sunto-Gun, Japan
- Hazard
- Software defect
- Quantity recalled
- 492 units
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
