Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1183-2021

February 05, 2021

Class III

Product summary

Firm
OraSure Technologies, Inc.
Event
Event 87340
Status
Terminated
Classification
Class III
Quantity
16 units
Official record key
device-enforcement:Z-1183-2021

Official wording

Reason: 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.

Code information: Lot 6681090, Exp date 2021-03. UDI: 608337000191

Distribution pattern: US Nationwide distribution in the states of KS, NJ, OH, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.