FDA Medical Device Recalls (openFDA)
Sky Medical Supplies and Equipments LLC: 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.
- Recall number
- Z-1127-2021
- Recalling firm
- Sky Medical Supplies and Equipments LLC
- 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.
- Status
- Terminated
- Initiated
- 2021-01-19
- Posted
- not on file
- Terminated
- 2026-03-10
- Reason
- Distributed COVID test kits without emergency use authorization.
- Root cause
- No Marketing Application
- Action
- Sky Medical initiated the recall on 01/19/2021 by telephone. The firm sent a follow-up letter disseminated by email on 02/03/2021. The firm is requesting the return of the product.
- Quantity
- 10,000 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
- Lot, serial or model codes
- 2020042901
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKO
- Firm FEI
- 3011895419
- Firm city
- Doral
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28