Rapid Response
BTNX Inc · Model D10.6-1G29-25 · UDI-DI 00722066003107
1
510(k) clearances
8
Adverse events
2
Recalls
49
Facilities
Description
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-26 | Siemens Healthcare Diagnostics, Inc. | out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h |
| 2003-11-17 | Abbott Health Products, Inc. | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
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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.