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OraSure Technologies, Inc. recalls Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C
Recalled March 17, 2021 · FDA recall Z-1183-2021 · OraSure Technologies
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. · FDA Class III
Units
16 units
Sold at
US Nationwide distribution in the states of KS, NJ, OH, VA.
Description
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.
Product
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Manufacturer(s)
OraSure Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →