FIRST SIGN®

HEMOSURE INC. · Model FSCCUP-14124-B300 · UDI-DI 00817763021858

LCM DIO DJG DKZ JXM DIS DJR LAF LFG LDJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

DOA 12 in 1 Test Cup, 25Pcs/Box without Box Label on Each Box; 12Boxes/Case; First Sign for Hemosure; CLIA Waived AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC

Recalls

Date	Firm	Reason
2005-05-31	Applied Biotech Inc	The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in

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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.