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CLIAwaived

Cliawaived, Inc. · Model CLIA-IDTC-6-60669 · UDI-DI 00816610020914

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510(k) clearances

Adverse events

Recalls

Facilities

Description

CLIAwaived,Inc. One Step Drug Test Cup-6 panel configuration (OPI300,BZO,BAR,MTD,OXY, TCA) -(25T/KIT)

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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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.