BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 00815381020529 /Lot # 2649724
- 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:
- BioFire Diagnostics, LLC
- Reason for Recall:
- Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Product Codes/Lot Numbers:
UDI: 00815381020529 /Lot # 2649724
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0602-2026
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