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DRI™ Fentanyl II Assay
ARK DIAGNOSTICS INC · Model 10028872 · UDI-DI 00812101030752
DJG
Prescription
10
510(k) clearances
24
Adverse events
13
Recalls
98
Facilities
Description
The DRI™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-06-12 | Ortho-Clinical Diagnostics, Inc. | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing qualit |
| 2020-01-20 | Carolina Liquid Chemistries Corp | Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labe |
| 2019-09-04 | Beckman Coulter Inc. | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive o |
| 2019-09-04 | Beckman Coulter Inc. | Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positiv |
| 2019-02-15 | Ameditech Inc | Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744) |
| 2018-03-12 | Siemens Healthcare Diagnostics, Inc. | Incorrect calibrator level listed in qualitative calibration steps |
| 2018-03-12 | Siemens Healthcare Diagnostics, Inc. | Incorrect calibrator level listed in qualitative calibration steps |
| 2014-02-18 | Lin-Zhi International Inc | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentratio |
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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.