FDA-Device2022-11-02Class II
ARIES SARS-CoV-2 Assay, REF: 50-10047
Luminex Corporation
Hazard
A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
Sold states
Distribution US nationwide, Indonesia, and Hong Kong.
Affected count
5,141 (24 Cassettes)
Manufactured in
12212 Technology Blvd, N/A, Austin, TX, United States
Products
ARIES SARS-CoV-2 Assay, REF: 50-10047
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0134-2023Don't want to check this manually?
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