Z-1127-2021Class II

AntIbody to SARS-CoV-2 -

Name: Z-1127-2021 AntIbody to SARS-CoV-2 -
Creator: Sky Medical Supplies and Equipments LLC
Published: 2021-01-19
License: https://open.fda.gov/license/

Sky Medical Supplies and Equipments LLC / initiated 2021-01-19 / Terminated

FDA source

Sky Medical Supplies and Equipments LLC began a recall of 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... on 2021-01-19. FDA classified it as Class II and gives the reason as "Distributed COVID test kits without emergency use authorization". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1127-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-19
Posted: 2021-02-16
Terminated: 2026-03-10
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.
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: Distributed COVID test kits without emergency use authorization.
FDA 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 in commerce: 10,000 kits
Distribution: Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Product codes and lots: 2020042901

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1127-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1127-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-16

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)