Aution™ Hybrid AU-4050 Chemical Analyzer
ARKRAY USA, INC. · Model 14603 · UDI-DI 00015482146030
Description
he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathological Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
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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