UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Reported: May 24, 2023 Initiated: April 5, 2023 #Z-1599-2023
Product Description
UA WIN 10 Kit, Catalog Number C52900, 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
- 306 units
- Distribution
- Worldwide Distribution
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis. Recalled by Beckman Coulter, Inc.. Units affected: 306 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-1599-2023.
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