ProterixBio SARS-CoV-2 Antibody Test Recalled for Inaccurate Results
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test kits are being recalled due to insufficient clinical performance data. The FDA determined test results may not be accurate, with potential false positives or false negatives.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a diagnostic test where clinical performance data is insufficient and test results may not be accurate. The product presents a risk of harm through potential false positives or false negatives, but no illnesses or injuries have been reported, meeting the rubric criterion for High severity.
Plain-English summary
ProterixBio is recalling 640 kits of the ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test and associated Dried Blood Spot Collection Kit. These kits are designed to detect IgG antibodies to SARS-CoV-2.
The U.S. Food and Drug Administration (FDA) concluded that the test is insufficiently supported by clinical performance data. Test results reported may not have been accurate, with potential for false positives or false negatives.
The recalled kits were distributed domestically to California, Colorado, Florida, Iowa, Massachusetts, Missouri, New Hampshire, New York, Ohio, Oklahoma, Texas, and Virginia. All product is subject to recall. Consumers and healthcare providers should not use these kits and should contact ProterixBio or their healthcare provider regarding previous test results or questions about test accuracy.
The recalled product
- Product
- ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
- Manufacturer
- PROTERIXBIO
- Hazard
- diagnostic-inaccuracy
- false-positive
- false-negative
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots were not coded. All product will be recalled.
Distribution
Distributed in 12 states:
- CA
- CO
- FL
- IA
- MA
- MO
- NH
- NY
- OH
- OK
- TX
- VA
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