OraSure Technologies, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1183-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: February 5, 2021

Date Posted: March 17, 2021

Recall Number: Z-1183-2021

Event ID: 87340

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.

Status: Terminated

Product Quantity: 16 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated