FDA-Device2023-05-24Class II
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc.
Hazard
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.
Sold states
Worldwide Distribution
Affected count
107 units
Manufactured in
11800 Sw 147th Ave, N/A, Miami, FL, United States
Products
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1597-2023Don't want to check this manually?
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