Counter, Urine Particle
Hematology · 21 CFR 864.5200
Recent MDR events
14 adverse event reports on file
- COBAS U 701 MICROSCOPY ANALYZERJan 7, 2026MalfunctionRoche Diagnostics1823260-2026-00081
- UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZERJul 23, 2021InjurySysmex Corporation, I Square1000515253-2021-00013
- UF-5000Aug 10, 2020InjurySysmex Corporation, I Square1000515253-2020-00022
- UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZERJan 31, 2020InjurySysmex Corporation, I Square1000515253-2020-00003
- SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZERJun 13, 2019MalfunctionSysmex Corporation, I Square1000515253-2019-00014
- SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWAREFeb 14, 2019MalfunctionSysmex Corporation1000515253-2019-00007
- UF-1000IJul 7, 2017InjurySysmex Corporation1000515253-2017-00030
- IQ200 AUTOMATED URINALYSIS SYSTEMOct 5, 2016MalfunctionIris International2023446-2016-00381
- UF-1000IAug 5, 2016InjurySysmex Corporation1000515253-2016-00021
- IQ200 AUTOMATED URINALYSIS SYSTEMJun 9, 2016MalfunctionIris International2023446-2016-00273
Event type breakdown
Recalls
6 recall events for this product code
- Beckman Coulter, Inc.Open, ClassifiedJan 25, 2024
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Z-0784-2024 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedJan 25, 2024
iQ200 Series Urine Microscopy Analyzers, Part Numbers:
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Z-0785-2024 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedJan 25, 2024
REV 2 Flowcell Capsule Spare, Part Number: C04154
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Z-0786-2024 · View FDA record ↗ - Beckman Coulter, Inc.Open, ClassifiedJan 25, 2024
iQ Waste Well Adapter, Part Number: 700-3393
Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
Z-0787-2024 · View FDA record ↗ - Sysmex America, Inc.TerminatedFeb 10, 2014
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal sam
The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data retention setting in the application. This resulted in the database files meeting its maximum capacity and causing system p
Z-0949-2014 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 70
Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).
Z-0914-2020 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
Sysmex America, Inc. - Vernon Hills
Vernon Hills, IL, US
Diamond Diagnostics Inc.
Budapest, HU
Arkray Factory Usa, Inc.
Miami, FL, US
Sysmex America, Inc.
Lincolnshire, IL, US
Sysmex Corporation Seishin Factory
Kobe Hyogo, JP
Sysmex Corporation
KOBE Hyogo, JP
Arkray, Inc.
Kamigyo-ku Kyoto, JP
Beckman Coulter, Inc.
Miami, FL, US
Sysmex Corporation I-square
Kakogawa Hyogo, JP
Arkray Factory, Inc.
Koka-shi Shiga, JP
Sysmex Corporation Techno Park
KOBE Hyogo, JP
Beckman Coulter, Inc.
CHASKA, MN, US
510(k) clearances
15 clearances for this product code
- Beckman Coulter, Inc.Sep 10, 2025
K252580 · iQ200 Series
- Arkray, Inc.May 3, 2024
K232416 · AUTION EYE AI-4510 Urine Particle Analysis System
- Beckman Coulter, Inc.Jul 2, 2021
K210127 · iQ200 System, iChemVELOCITY Automated Urine Chemistry System
- Roche DiagnosticsNov 6, 2020
K200811 · cobas u 701 microscopy analyzer
- Sysmex America, Inc.Apr 23, 2018
K171883 · Sysmex UF-5000 Fully Automated Urine Particle Analyzer
- Iris International, Inc.Feb 5, 2010
K093861 · IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
- Sysmex America, Inc.Feb 3, 2009
K083002 · SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER
- Sysmex America, Inc.May 2, 2008
K080887 · SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE