Recall Z-3332-2026 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Beckman Coulter Mishima K.K.
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.
| Date | Oct 1, 2026 (initiated Aug 3, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 |
| Quantity | 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, Fr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc., Jun 9, 1998 |