Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of Recalled by OraSure Technologies, Inc. Due to Incorrect lot of Substrate Reagent (TMB) may be...

Date: February 5, 2021
Company: OraSure Technologies, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OraSure Technologies, Inc. directly.

Affected Products

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

Quantity: 16 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OraSure Technologies, Inc.

OraSure Technologies, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report