Beckman Coulter DxC 500 AU Analyzer Software Defect Recall
Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules due to a software defect that may cause erroneous patient test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where erroneous patient test results could lead to incorrect medical decisions, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling DxC 500 AU Clinical Analyzer Modules and DxC 500 AU Clinical Chemistry Analyzers. The recall involves specific modules using software version 1.5 or lower, including AU w/out ISE (Part Number C63519) and AU w/ISE (Part Number C63520). The products were distributed worldwide and nationwide in the US.
The recall is due to a software defect in the Parameter Package (PP) import logic. When a new Parameter Package version is imported to a system that already has an existing Parameter Package onboard, the logic overwrites all predefined calculated test rules, including those previously modified by the user. This causes user-customized calculated test rules to revert silently to their default expressions. As a result, the instruments may generate erroneous patient test results without providing an explicit error notification. The issue only affects instruments running software version 1.5 or lower and does not affect new installations.
Healthcare facilities using these instruments should contact Beckman Coulter Inc. for further instructions on how to address the software defect.
The recalled product
- Product
- Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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 (3)
- 1) Part Number C63519
- UDI/DI 14987666545058 2) Part Number C63520
- UDI/DI 14987666545065
Distribution
Distributed nationwide across the United States.
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