PROTERIXBIO recalls ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model nu…

Recall date

April 17, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1058-2022

FDA classification

Class II

Brand / firm

PROTERIXBIO

Sold / distributed

Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number