ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots were not coded. All product will be recalled.
- 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:
- PROTERIXBIO
- Reason for Recall:
- FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Product Codes/Lot Numbers:
Lots were not coded. All product will be recalled.
Distribution:
Distributed in: CA, CO, FL, IA, MA, MO, NH, NY, OH, OK, TX, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1058-2022