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Healgen Scientific Limited Liability Company · Model HCDOAF-5114A6 · UDI-DI 00816490021698

LAF DJG JXM DIS LCM DJR LFG DKZ LDJ DIO Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

11 Panel DOA Test Clear Flat Cup +Adulterant Test StripsOXI/SG/pH +GLU/CRE/NIT

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.