Home › Device types › LKM
Counter, Urine Particle
FDA product code LKM · Class 2 · Hematology
9
Registered devices
14
Adverse events
6
Recalls
15
510(k) clearances
Devices with this code
Fully Automated Urine Particle Analyzer UF-1000i — SYSMEX CORPORATIONiQ200 — BECKMAN COULTER IRELAND INC.AUTION EYE™ AI-4510 Analyzer — ARKRAY USA, INC.iQ200 — BECKMAN COULTER IRELAND INC.iQ200 — BECKMAN COULTER IRELAND INC.iQ®200 — IRIS INTERNATIONAL, INC.Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software — Sysmex America, Inc.Fully Automated Urine Particle Analyzer UF-5000 — SYSMEX CORPORATIONiQ200 — BECKMAN COULTER IRELAND INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-19 | Beckman Coulter, Inc. | 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 |
| 2023-12-19 | Beckman Coulter, Inc. | 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 |
| 2023-12-19 | Beckman Coulter, Inc. | 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 |
| 2023-12-19 | Beckman Coulter, Inc. | 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 |
| 2019-10-28 | Beckman Coulter Inc. | Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record N |
| 2013-03-31 | Sysmex America, Inc. | 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 fil |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.