ProterixBio SARS-CoV-2 — Class II medical device recall Z-1058-2022
Terminated recall by PROTERIXBIO, reported 2022-05-18, distributed in CA, CO, FL, IA, MA, MO, NH, NY…. FDA review concluded that the test is insufficiently supported by clinical performance data, and results repor
| Recall number | Z-1058-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PROTERIXBIO, Billerica, MA, United States |
| Recall initiated | 2022-04-17 |
| Classified | 2022-05-11 |
| Reported by FDA | 2022-05-18 |
| Terminated | 2024-01-23 |
| Distributed | CA, CO, FL, IA, MA, MO, NH, NY, OH, OK, TX, VA |
| Quantity | 640 kits |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1058-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.