FDA recall Z-1127-2021

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-01-19

Report date

2021-02-24

Termination date

2026-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2021