DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Reported: May 24, 2023 Initiated: April 5, 2023 #Z-1598-2023
Product Description
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Reason for Recall
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 355 units
- Distribution
- Worldwide Distribution
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis. Recalled by Beckman Coulter, Inc.. Units affected: 355 units.
Why was this product recalled? ▼
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1598-2023.
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