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PreChek Multi-Drug Test Cup

IDUN SOLUTIONS LLC · Model IDOA-7225RC-5P · UDI-DI 00857275007162

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1
510(k) clearances
8
Adverse events
2
Recalls
48
Facilities

Description

5 tests kit, 12 test items Cup; AMP/COC/OXY/THC/PCP/MDMA/MOP/BZO/BAR/MET/MTD/TCA

Recalls

DateFirmReason
2026-06-26Siemens 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
2003-11-17Abbott Health Products, Inc.Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.

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Data 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.