Sky Medical Supplies and Equipments LLC: Medical Device Recall in 2021 - (Recall #: Z-1127-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 19, 2021

Date Posted: February 24, 2021

Recall Number: Z-1127-2021

Event ID: 87300

Reason for Recall:

Distributed COVID test kits without emergency use authorization.

Status: Terminated

Product Quantity: 10,000 kits

Code Information:

2020042901

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.

Voluntary or Mandated:

Voluntary: Firm initiated