Recall Z-1058-2022— PROTERIXBIO

Name: FDA recall Z-1058-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-17

Class II · Terminated

Class II FDA medical device recall by PROTERIXBIO, initiated 2022-04-17, terminated 2024-01-23. FDA's recall record names no specific 510(k) clearance for this event. Product: ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number. Reason: 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)..

Recalling firm: PROTERIXBIO
Classification: Class II
Status: Terminated
Initiated: 2022-04-17
Terminated: 2024-01-23
Firm location: Billerica, MA, United States

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.