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FIRST SIGN®

HEMOSURE INC. · Model FSCDIP12104 · UDI-DI 00817763021315

LAF JXM DIS DKZ DIO DKE DJR DJG 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/BUP/BZO/COC/mAMP/MTD/OPI/OXY/THC

Recalls

Date	Firm	Reason
2021-02-05	OraSure Technologies, Inc.	Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but

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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.