Urine Analysis Diagnostic Device Software Issue Prevents Carryover Detection
Beckman Coulter is recalling UA WIN 10 diagnostic kits because an optional software flag for detecting sample carryover was enabled but not displayed, preventing proper investigation of potential test contamination.
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: This is an FDA Class II recall of a diagnostic device where a software issue prevents investigation of sample carryover. No illnesses or injuries are reported, but the inability to detect potential contamination events represents a risk of diagnostic inaccuracy.
Plain-English summary
Beckman Coulter, Inc. is recalling the UA WIN 10 Kit, Catalog Number C52900, an in-vitro diagnostic device used for urine analysis. The recall affects approximately 306 units worldwide running Windows 10 with Software Versions 8.5, 8.5.1, and 8.6.
The issue is an intermittent software problem where an optional flag labeled 'Previous Sample Had Sperm' was enabled but not displayed to users. When users could not see this flag, they could not properly investigate carryover events—instances where material from one sample contaminates results from subsequent samples being tested on the same analyzer.
The recalled product
- Product
- UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 306
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 (4)
- UDI/DI 15099590735982
- All analyzers with Windows 10
- Software Versions 8.5
- 8.5.1 and 8.6
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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