Healgen COVID-19 IgG/IgM Rapid Test Cassette — Class II medical device recall Z-1125-2021
Terminated recall by Confirm Biosciences Inc, reported 2021-02-24, distributed nationwide. Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Auth
| Recall number | Z-1125-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Confirm Biosciences Inc, San Diego, CA, United States |
| Recall initiated | 2021-01-29 |
| Classified | 2021-02-16 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2022-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BO, BR, BS, CA, CH, DO, EC, ES, GB, GH, GR, GT, HN, IL, IN, KW, MX, PA, PT, QA, RO, SA, SI, TR, ZA |
| Quantity | 563,840 cassettes |
| Lot numbers | 2006167EUA, 2006168EUA, 2006169EUA |
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum.
Reason for recall
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test Cassettes were not adequately validated for its intended use (fingerstick tests for in-home use/testing).
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-1125-2021. 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.