Teco Diagnostics Uritek TC-201 Urine Chemistry Test System
TECO DIAGNOSTICS · Model TC-201 · UDI-DI 10673486000511
Description
Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 event could have |
| 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 event could have |
| 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 event could have be |
| 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 event could have |
| 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 observed at creatinin |
| 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: charring and/or mel |
| 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: charring and/or me |
| 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. |
| 2020-01-21 | Sysmex 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 and/or sparks which |
| 2019-11-07 | Beckman Coulter Inc. | Beckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the iChemVELOCITY Urine Chemistry System that prevents the trigger of a chemistry sys |
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