Home › Device types › KQO
Automated Urinalysis System
FDA product code KQO · Class 1 · Clinical Chemistry
119
Registered devices
1,091
Adverse events
35
Recalls
46
510(k) clearances
Devices with this code
cobas u 411 Urine Analyzer — Roche Diagnostics GmbHMoore Medical — MOORE MEDICAL LLCURINE REAGENT STRIPS — Urit Medical Electronic Co., Ltd.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.My Yodoc — S-CONNECT CO.,LTDCARDINAL HEALTH — Cardinal Health 200, LLCAution™ Hybrid AU-4050 Chemical Analyzer — ARKRAY USA, INC.AUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.AUTION EYE™ Calibrator Focus/Calibrator — ARKRAY USA, INC.iChem Velocity — BECKMAN COULTER IRELAND INC.Urine Chemistry Strips — Urit Medical Electronic Co., Ltd.AIMSTRIP US-4 — GERMAINE LABORATORIES, INCAutomatic Urine Analyzer — Urit Medical Electronic Co., Ltd.AUTION™ Staining Solution SED — ARKRAY USA, INC.Clinitek Atlas® Rinse Additiive — Siemens Healthcare Diagnostics Inc.Pro Advantage — NATIONAL DISTRIBUTION & CONTRACTING, INC.AIMSTRIP URINE AUTO ANALYZER — GERMAINE LABORATORIES, INCMISSION U500 URINE ANALYZER — Acon Laboratories, Inc.AUTION™ Sticks 10EA Test Strips — ARKRAY USA, INC.LOOKEE® AscleTrack™ Urine Test Analyzer — Kunming Lianen Biotechnology Co., LTDUrine Reagent Strips — Urit Medical Electronic Co., Ltd.Rapid Response — BTNX InciQ200 — BECKMAN COULTER IRELAND INC.MISSION U500 URINE ANALYZER — Acon Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-12 | Beckman Coulter, Inc. | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the |
| 2026-08-12 | Beckman Coulter, Inc. | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the |
| 2023-04-05 | Beckman Coulter, Inc. | 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 carryov |
| 2023-04-05 | Beckman Coulter, Inc. | 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 carryov |
| 2023-04-05 | Beckman Coulter, Inc. | 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 |
| 2023-04-05 | Beckman Coulter, Inc. | 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 carryov |
| 2021-10-18 | Roche Diagnostics Operations, Inc. | A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was o |
| 2020-03-30 | Beckman Coulter Inc. | A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes |
| 2020-03-30 | Beckman Coulter Inc. | A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: |
| 2020-02-17 | Beckman Coulter, Inc. | The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips. |
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