Reported Aug 24, 2022 · Ongoing
ARIES SARS-CoV-2 Assay
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101
Is this the product you have?
- ARIES SARS-CoV-2 Assay
- Lot codes and dates
- LotAB4042A
- Amount recalled
- 257
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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