Z-1599-2023 Class II Ongoing
FDA device recall Z-1599-2023 was initiated by Beckman Coulter, Inc. on April 5, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 306 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 306 units
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.
Distribution Pattern
Worldwide Distribution
Code Information
UDI/DI 15099590735982, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6