Luminex Corporation recalls ARIES SARS-CoV-2 Assay
Recalled Product
ARIES SARS-CoV-2 Assay
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot: AB4042A
View official government recall
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