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.
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: 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.
- Affected units
- 107
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.
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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