xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.
- 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 Molecular Diagnostics
- Reason for Recall:
- Reports have been received of lower MS2 MFI values when using the panel.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
Product Codes/Lot Numbers:
Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.
Distribution:
Distributed in: AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1767-2019
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