FDA recall Z-1058-2022

PROTERIXBIO · Class II · device

Product

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).

Distribution

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

Key facts

Status: Terminated
Initiation date: 2022-04-17
Report date: 2022-05-18
Termination date: 2024-01-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1058-2022