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PROTERIXBIO Recalls
1 recall on record · May 18, 2022 to May 18, 2022 · Medical Devices
May 18, 2022
Medical Devices
FDA
PROTERIXBIO recalls ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model num
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).
PROTERIXBIO Recalls | RecallWatchUSA