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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 12 Results
510(K) Number: K022774
 
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REV 2 Flowcell Capsule Spare, Part Number: C04154 2 01/25/2024 Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345,... 2 01/25/2024 Beckman Coulter, Inc.
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947 2 01/25/2024 Beckman Coulter, Inc.
iQ Waste Well Adapter, Part Number: 700-3393 2 01/25/2024 Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 2... 2 05/17/2023 Beckman Coulter, Inc.
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine ana... 2 05/17/2023 Beckman Coulter, Inc.
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis 2 05/17/2023 Beckman Coulter, Inc.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine an... 2 05/17/2023 Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer- All part numbers 2 05/09/2020 Beckman Coulter Inc.
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 70... 2 01/29/2020 Beckman Coulter Inc.
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