Recall Z-1009-2022— MESA BIOTECH, INC
Class I · Ongoing
Class I FDA medical device recall by MESA BIOTECH, INC, initiated 2022-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Accula SARS-CoV-2 Test, REF: COV4100. Reason: SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment..
- Recalling firm
- MESA BIOTECH, INC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-04-06
- Firm location
- San Diego, CA, United States
Product description
Accula SARS-CoV-2 Test, REF: COV4100
Reason for recall
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.