Home / Recalls / Medical Devices
Luminex Corporation recalls ARIES SARS-CoV-2 Assay
Recalled August 24, 2022 · FDA recall Z-1524-2022 · Luminex
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. · FDA Class II
Units
257
Sold at
U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Description
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.
Product
ARIES SARS-CoV-2 Assay
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →