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Luminex Corporation Recall 90698

Description: ARIES SARS-CoV-2 Assay

Luminex Corporation Recall 90698 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1524-2022
Event ID90698
Event DescriptionARIES SARS-CoV-2 Assay
Product TypeDevices
DistributionU.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Recall ReasonSARS-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.
Device Classification20220824
Device Code InfoLot: AB4042A
Center Classification Date20220817
Recall Initiation Date20220714
Recalling FirmLuminex Corporation
Initial Notification Letter
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