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.
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 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.
- Affected units
- 355
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.
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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