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URiSCAN Optima
YD Diagnostics CORP. · Model Optima · UDI-DI 08806125619033
1
510(k) clearances
1,089
Adverse events (1 deaths)
33
Recalls
65
Facilities
Description
The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
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 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 |
| 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 |
| 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 instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or me |
| 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 |
| 2020-02-17 | 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.