Z-1183-2021 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- February 5, 2021
- Termination Date
- March 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units
Product Description
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 Pattern
US Nationwide distribution in the states of KS, NJ, OH, VA.
Code Information
Lot 6681090, Exp date 2021-03. UDI: 608337000191