The Recall Desk
HighFDA (Devices)·Z-1598-2023·Announced 2023-05-24

Urine Microscopy Analyzer Software Defect May Prevent Carryover Detection

Beckman Coulter is recalling the DxU 840m Iris Urine Microscopy Analyzer due to a software issue where a carryover detection flag may fail to display, potentially resulting in undetected sample contamination and incorrect test results.

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 a Class II medical device recall involving a diagnostic instrument with a risk-of-harm defect. Although no adverse events have been reported, the software malfunction could prevent users from detecting sample carryover, potentially leading to incorrect test results that could affect patient care decisions.

Plain-English summary

Beckman Coulter, Inc. is recalling the DxU 840m Iris Urine Microscopy Analyzer (Catalog Number C76947), an in-vitro diagnostic device used for urine analysis. Approximately 355 units have been distributed worldwide.

The device has an intermittent software defect affecting systems with Windows 10 running Software Versions 8.5, 8.5.1, and 8.6. The optional flag "Previous Sample Had Sperm" may be enabled but not displayed on the user interface. When this occurs, the analyzer cannot properly alert users to investigate potential sample carryover between consecutive patient samples.

Sample carryover is a quality control concern in urine analysis, as contamination from a previous patient's sample could affect the accuracy of the current patient's results. Healthcare facilities using affected analyzers should review their quality control procedures. Affected users should contact Beckman Coulter for technical guidance regarding their specific devices.

The recalled product

Product
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Diagnostic Equipment / Urine Analysis
Hazard
  • software-malfunction
  • 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 15099590748654
  • 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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