Z-1597-2023 Class II Ongoing
FDA device recall Z-1597-2023 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: 107 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
- 107 units
Product Description
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, 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 15099590748647, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6