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FDAFebruary 5, 2021device

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 contained Substrate Reagent (TMB) lot 6679623, should not affect performance.

What to do

FDA enforcement status: Terminated

Brands named

orasure technologiesorasure

UPCs

608337000191

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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