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Automated Urinalysis System

FDA product code KQO · Class 1 · Clinical Chemistry

104
Registered devices
1,086
Adverse events
33
Recalls
46
510(k) clearances

Devices with this code

Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System — TECO DIAGNOSTICSMoore Medical — MOORE MEDICAL LLCRapid Response — BTNX IncCONTEC — Contec Medical Systems Co., Ltd.AIMSTRIP URINE ANALYZER — GERMAINE LABORATORIES, INCCARDINAL HEALTH — Cardinal Health 200, LLCRapid Response — BTNX IncUri-Trak 120 Analyzer Refurbished — STANBIO LABORATORY, L.P.My Yodoc — S-CONNECT CO.,LTDAUTION™ Diluent BAC — ARKRAY USA, INC.CLINITEK Novus® 10 Urinalysis Cassette 450 — Siemens Healthcare Diagnostics Inc.CLINITEK Status® Connector — Siemens Healthcare Diagnostics Inc.Moore Medical — MOORE MEDICAL LLCcobas u 601 urine analyzer — Roche Diagnostics GmbHMission U120 Urine Analyzer — Acon Laboratories, Inc.AIMSTRIP US-4 — GERMAINE LABORATORIES, INCiChem Velocity — BECKMAN COULTER IRELAND INC.CARDINAL HEALTH — Cardinal Health 200, LLCAIMSTRIP 10-SG — GERMAINE LABORATORIES, INCAUTION™ MAX AX-4022 Analyzer — ARKRAY USA, INC.AUTION™ Uriflet 9HA Test Strips — ARKRAY USA, INC.AIMSTRIP US-K — GERMAINE LABORATORIES, INCClinitek Atlas® Calibrator #4 — Siemens Healthcare Diagnostics Inc.Automatic Urine Analyzer — Urit Medical Electronic Co., Ltd.

Recent recalls

DateFirmReason
2023-04-05Beckman 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
2023-04-05Beckman 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
2023-04-05Beckman 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
2023-04-05Beckman 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
2021-10-18Roche 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
2020-03-30Beckman 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:
2020-03-30Beckman 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
2020-02-17Beckman Coulter, Inc.The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.
2020-01-21Sysmex America, Inc.When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke
2019-11-07Beckman Coulter Inc.Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigge

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.