Recall Z-1524-2022— Luminex Corporation
Class II · Ongoing
Class II FDA medical device recall by Luminex Corporation, initiated 2022-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ARIES SARS-CoV-2 Assay. Reason: 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..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-14
- Firm location
- Austin, TX, United States
Product description
ARIES SARS-CoV-2 Assay
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.