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Healgen (Private Label) - 3124

CONFIRM BIOSCIENCES, INC. · Model CB-HE-3124 · UDI-DI 00895330002790

LFG DIO DKE DJG LCM DJF JXM DIS DJR DKZ DJC

510(k) clearances

Adverse events

Recalls

Facilities

Description

12 Panel Dip Card - CLIA - COC,THC,OPI,AMP,PCP,TCA,BZO,BAR,MTD,MDMA,OXY,BUP

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.