Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Accula SARS-CoV-2 Test Recalled by MESA BIOTECH, INC Due to SARS-CoV-2 Test has an increased potential for false...

Date: April 6, 2022
Company: MESA BIOTECH, INC
Status: Ongoing
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 MESA BIOTECH, INC directly.

Affected Products

Accula SARS-CoV-2 Test, REF: COV4100

Quantity: 6162

Why Was This Recalled?

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MESA BIOTECH, INC

MESA BIOTECH, INC has 1 total recall tracked by RecallDetector.

Related Recalls

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