NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025
- 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 Inc
- Reason for Recall:
- Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Product Codes/Lot Numbers:
Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0043-2025
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