The Recall Desk
HighFDA (Devices)·Z-1597-2023·Announced 2023-05-24

Beckman Coulter Urine Analyzer Software Flag Display Issue Affects Carryover Detection

Beckman Coulter is recalling 107 DxU 850m Iris Urine Microscopy Analyzers worldwide due to an intermittent software issue where a quality-control flag is enabled but not displayed, potentially preventing detection of sample carryover 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: FDA Class II recall affecting a medical device's quality control capability. While no illnesses or injuries have been reported, the software display failure creates a risk that sample contamination could go undetected, potentially leading to inaccurate diagnostic results.

Plain-English summary

Beckman Coulter, Inc. is recalling the DxU 850m Iris Urine Microscopy Analyzer (Catalog Number C49513), an in-vitro diagnostic device used for urine analysis. The recall affects 107 units with Windows 10 and software versions 8.5, 8.5.1, or 8.6, distributed worldwide.

An intermittent software issue has been identified in these analyzers. An optional flag labeled "Previous Sample Had Sperm" can become enabled but will not display on the device. This flag is used to alert operators to investigate potential carryover contamination—the transfer of material from one sample to the next—which is an important quality control measure.

When the flag is not displayed despite being enabled, operators may not be aware that a sample could have carryover contamination, and may not investigate or address the issue. This could result in inaccurate urine analysis results.

The recalled product

Product
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Manufacturer
Beckman Coulter, Inc.
Category
Medical Device — Diagnostic Device / Urine Analysis
Hazard
  • software-defect
  • carryover-contamination

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 15099590748647
  • 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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