Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU48…
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 product
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Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 onlyUDI-DI codesUDI number
What the firm is doing
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
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3332-2026
- FDA 510(k) clearance · K981743The device's official FDA premarket clearance record
- FDA device classification · JJEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 862.2160The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Beckman Coulter Mishima K.K.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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