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ReliOn Home Drug Test Kit 12 Panel
CONFIRM BIOSCIENCES, INC. · Model RO-DR0012 · UDI-DI 00895330002394
10
510(k) clearances
25
Adverse events
13
Recalls
98
Facilities
Description
Home Drug Test Kit 12 Panel AMP BAR BZD COC MET MOR MTD OXY PCP TCA THC XTC
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.