Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
- 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:
- Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Product Codes/Lot Numbers:
Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010
Distribution:
Distributed in: US, TX, CT, LA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0920-2022
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.