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U.S. Department of Health and Human Services

Class 2 Device Recall BECKMAN COULTER CHEMISTRY ANALYZER AU480

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 Class 2 Device Recall BECKMAN COULTER CHEMISTRY ANALYZER AU480see related information
Date Initiated by FirmAugust 03, 2026
Date PostedOctober 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3332-2026
Recall Event ID 99588
510(K)NumberK981743 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductSystems/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.
Code Information 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.)
FEI Number 3002807663
Recalling Firm/
Manufacturer		 Beckman Coulter Mishima K.K.
454-32
Higashino; Nagaizumi-Cho
Sunto-Gun Japan
Manufacturer 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 Determined
Cause 2		Software design
ActionOn 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 Commerce492 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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