AntIbody to SARS-CoV-2 — Class II medical device recall Z-1127-2021
Terminated recall by Sky Medical Supplies and Equipments LLC, reported 2021-02-24, distributed nationwide. Distributed COVID test kits without emergency use authorization.
| Recall number | Z-1127-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sky Medical Supplies and Equipments LLC, Doral, FL, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-02-16 |
| Reported by FDA | 2021-02-24 |
| Terminated | 2026-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | PE |
| Quantity | 10,000 kits |
Product
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
Reason for recall
Distributed COVID test kits without emergency use authorization.
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-1127-2021. 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.