Product Safety Recalls

Product Recall Tracker

Luminex Corporation Recall 90698

Description: ARIES SARS-CoV-2 Assay

Luminex Corporation Recall 90698 Information

StatusOngoing
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.
Quantity257
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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.