Class II — AZURE BIOTECH INC
| Recalling firm | Azure Biotech Inc |
|---|---|
| Registered facility | AZURE BIOTECH INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24 month expiration dating. |
| 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 U… |
| Quantity | Total 100,000 kits (FaStep and EcoTest Rapid Diagnostic Test kits) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of CA. FL, GA, IL, LA, MD, MN, NC, TX, UT, VA and WA. The country of Canada. |
| Initiated | 2021-03-02 |
| Classified | 2021-04-16 |
| Terminated | 2023-03-31 |
| Recall number | Z-1432-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AZURE BIOTECH INC (Z-1432-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87541/
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