FDA Device recall Z-1058-2022
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
- FDA Device
- Class II
- terminated
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number by Proterixbio, citing 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).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1058-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-17 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Proterixbio |
| Distribution | CA, CO, FL, IA, MA, MO, NH, NY, OH, OK, TX, VA |
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).
Identifiers
| code_info | Lots were not coded. All product will be recalled. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1058-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.