Device product
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Z-1058-2022
Product summary
- Firm
- PROTERIXBIO
- Event
- Event 90107
- Status
- Terminated
- Classification
- Class II
- Quantity
- 640 kits
- Official record key
device-enforcement:Z-1058-2022
Official wording
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).
Code information: Lots were not coded. All product will be recalled.
Distribution pattern: Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA
Derived failure modes
-
Unknown
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).