FDA-Device2022-08-24Class II
ARIES SARS-CoV-2 Assay
Luminex Corporation
Hazard
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
Sold states
U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Affected count
257
Manufactured in
12212 Technology Blvd, Austin, TX, United States
Products
ARIES SARS-CoV-2 Assay
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2022Don't want to check this manually?
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