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AUTION™ Sticks 9EB Test Strips
ARKRAY USA, INC. · Model 73627 · UDI-DI 00015482736279
1
510(k) clearances
1,089
Adverse events (1 deaths)
33
Recalls
65
Facilities
Description
Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.
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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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.