medical Class II Updated 2022-08-24

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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