ARIES SARS-CoV-2 Assay
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot: AB4042A
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Luminex Corporation
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ARIES SARS-CoV-2 Assay
Product Codes/Lot Numbers:
Lot: AB4042A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1524-2022
Related Recalls
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Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Class I - Dangerous
Potentially defective utility trays in the reagent kits.