Z-3332-2026

Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code...

Name: Z-3332-2026 Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code...
Creator: Beckman Coulter Mishima K.K.
Published: 2026-08-03
License: https://open.fda.gov/license/

Beckman Coulter Mishima K.K. / initiated 2026-08-03 / Open, Classified

FDA source

Recall record

Recall number: Z-3332-2026
Status: Open, Classified
Initiated: 2026-08-03
Posted: 2026-10-01
Recalling firm: Beckman Coulter Mishima K.K.
Product: 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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
FDA root cause: Software design
Action: On 08/03/2026, an "URGENT MEDICAL DEVICE RECALL" Letter was sent via postal mail and email informing customers that CHEMISTRY ANALYZER AU480 with Windows 10 IoT Enterprise 2021 LTSC PCsmay 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. Customers are instructed to: 1. Be sure to create a new index once or more per day at an appropriate time. Refer to 5.1 Start the System of the IFU to complete this action. 2. Beckman Coulter recommends posting this letter on or near the affected analyzers. Resolution - Beckman Coulter has identified the root cause and will resolve the issue by applying a Software solution to the impacted systems. BEC service teamwill contact customers to schedule the Software solution application, and a Field Service Engineer (FSE) will perform the on-site work. For questions - contact Customer Support Center at: http://www.beckmancoulter.com
Quantity in commerce: 492 units
Distribution: 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.
Product codes and lots: 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.)

Product code JJE

K981743Class IIOlympus Au400 Clinical Chemistry AnalyzerOlympus America, Inc. / cleared 1998-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)