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FIRST SIGN®

HEMOSURE INC. · Model FSCDIP1104 · UDI-DI 00817763021575

LFG LCM DIS LDJ DJR LAF DIO JXM DJG DKZ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

DOA 10 in 1 Test Dip Card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC

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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.