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OraSure Technologies, Inc. Recall 87340

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

OraSure Technologies, Inc. Recall 87340 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1183-2021
Event ID87340
Event DescriptionMethamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Product TypeDevices
DistributionUS Nationwide distribution in the states of KS, NJ, OH, VA.
Quantity16 units
Recall ReasonIncorrect 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.
Device Classification20210317
Device Code InfoLot 6681090, Exp date 2021-03. UDI: 608337000191
Center Classification Date20210305
Recall Initiation Date20210205
Recalling FirmOraSure Technologies, Inc.
Initial Notification Letter
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