The Recall Desk
HighFDA (Devices)·Z-1599-2023·Announced 2023-05-24

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.

What this means for you

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.
Category
Medical Device — Diagnostic / Urine Analysis
Hazard
  • sample-carryover
  • diagnostic-inaccuracy

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.

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