FDAApril 17, 2022device
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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).
What to do
FDA enforcement status: Terminated
Brands named
proterixbio
Recall history
No related federal recalls on record for this brand yet.
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