Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test Recalled by PROTERIXBIO Due to FDA review concluded that the test is insufficiently...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PROTERIXBIO directly.
Affected Products
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Quantity: 640 kits
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed to 12 states: CA, CO, FL, IA, MA, MO, NH, NY, OH, OK, TX, VA
About PROTERIXBIO
PROTERIXBIO has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report