San Diego, CA, United States
MESA BIOTECH, INC recalls
1 recall recorded since 2018, most recently on 6 April 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 6 April 2022
- Reason
- SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
- Distribution
- US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1009-2022
- Accula SARS-CoV-2 Test, REF: COV4100
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.