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CHEMTRON BIOTECH INC · Model 712K03A-G · UDI-DI 00812203030728

LAF LDJ DJR DJC JXM DIO DKZ DJG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

11 Panel DOA Cup, AMP300/BZO200/BUP/COC150/MDMA/MET300/MTD/MOR/OXY/THC/FYL5/A-strips(Cr/SG/Ox)/(Ni/pH/Gl), 25tests/kit

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.