medical Class II Updated 2022-05-18

PROTERIXBIO recalls ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associat

Recalled Product

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

Hazard / Issue

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).

Issued by

FDA

Affected States: CA, CO, FL, IA, MA, MO, NH, NY, OH, OK, TX, VA
Lot/Code Info: Lots were not coded. All product will be recalled.
View official government recall

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