Beckman Coulter AU480 Chemistry Analyzer Software Error Recall
Beckman Coulter is recalling AU480 Chemistry Analyzers because a software error prevents the instrument from starting, delaying patient results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in obtaining patient results due to software failure, which is a significant operational issue but does not involve direct physical injury or death.
Plain-English summary
Beckman Coulter Mishima K.K. is recalling certain AU480 Chemistry Analyzers. These devices are used for in vitro diagnostic testing to measure analytes in samples. The recall involves 492 units distributed worldwide, including in the United States and numerous other countries.
The recall is due to a software issue on the pre-installed Windows 10 IoT Enterprise 2021 LTSC PCs. When launching the instrument software, the device may display the message "System Stopped By Fatal Error: DBConnectionError AlarmDB." This error makes the AlarmDB unreadable and prevents the instrument software from starting. As a result, there is a delay in obtaining patient results.
Affected units are identified by specific item numbers and UDI-DI codes, including B96692, B96693, and B12183. Users should contact Beckman Coulter Mishima K.K. for instructions on how to resolve the software issue.
The recalled product
- 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…
- Manufacturer
- Beckman Coulter Mishima K.K.
- Affected units
- 492
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- the UDI number is not available.)
Distribution
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