Home › ARKRAY USA, INC. › AUTION™ Staining Solution SED
AUTION™ Staining Solution SED
ARKRAY USA, INC. · Model 73809 · UDI-DI 04987486738091
1
510(k) clearances
1,091
Adverse events (1 deaths)
35
Recalls
68
Facilities
Description
Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-12 | Beckman Coulter, Inc. | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replace |
| 2026-08-12 | Beckman Coulter, Inc. | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replace |
| 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 |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.