OraSure Technologies, Inc. recalls Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041…
- Recall date
- February 5, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1183-2021
- FDA classification
- Class III
- Brand / firm
- OraSure Technologies, Inc.
- Sold / distributed
- US Nationwide distribution in the states of KS, NJ, OH, VA.
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
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