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Luminex Corporation recalls ARIES SARS-CoV-2 Assay, REF: 50-10047
Recalled November 2, 2022 · FDA recall Z-0134-2023 · Luminex
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. · FDA Class II
Units
5,141 (24 Cassettes)
Sold at
Distribution US nationwide, Indonesia, and Hong Kong.
Description
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.
Product
ARIES SARS-CoV-2 Assay, REF: 50-10047
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →