Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label — Class II medical device recall Z-1432-2021
Terminated recall by AZURE BIOTECH INC, reported 2021-04-28, distributed nationwide. Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expira
| Recall number | Z-1432-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AZURE BIOTECH INC, Houston, TX, United States |
| Recall initiated | 2021-03-02 |
| Classified | 2021-04-16 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2023-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 100,000 kits |
| Reason classes | labeling |
| Lot numbers | I2004001, I2004003, I2005023, I2006030, I2006128 |
Product
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only *** For in vitro diagnostic use only, and 2) Pouch Label - ECOTEST RAPID DIAGNOSTIC TEST *** /Rapid / Reliable / Simple/ *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - ECOTEST RAPID DIAGNOSTIC TEST *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device *** For Professional in vitro diagnostic use only *** For Emergency Use Authorization Only.
Reason for recall
Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating.
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-1432-2021. 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.