FDA Device recall Z-1127-2021
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medic…
- FDA Device
- Class II
- terminated
- Published 2021-02-24
On 2021-02-24 the FDA classified a Class II recall of AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medic… by Sky Medical Supplies And Equipments, citing distributed COVID test kits without emergency use authorization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1127-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-19 |
| Published | 2021-02-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sky Medical Supplies And Equipments |
| Distribution | US |
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
Distributed COVID test kits without emergency use authorization.
Identifiers
| code_info | 2020042901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.