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PROTERIXBIO recalls ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model num
Recalled May 18, 2022 · FDA recall Z-1058-2022 · PROTERIXBIO
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). · FDA Class II
Units
640 kits
Sold at
Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Description
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).
Product
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Manufacturer(s)
PROTERIXBIO
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →