FDA recall Z-1183-2021

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-02-05

Report date

2021-03-17

Termination date

2023-03-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2021