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Healgen Scientific Limited Liability Company · Model HCDOAV-5125SF7 · UDI-DI 00810173655941

LAF LCM DJR LFG DIS JXM DJG DIO LDJ DKZ JXN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

K243365 12 Panel Cup Type #22 with Clicker, Nor-FEN and Low cutoff: AMP500, BAR300, BUP10, BZO300, COC150, NOR-FEN5, MDMA500, MET500, MOP300, MTD300, OXY100, THC50

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.