ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers AB3600A and AB3560A
- 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:
- Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Product Codes/Lot Numbers:
Lot Numbers AB3600A and AB3560A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0553-2022
Related Recalls
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Potentially defective utility trays in the reagent kits.