Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Company

Sml Distribution, Llc

Recall Initiated

March 4, 2022

Recall Number

Z-0944-2022

Quantity

209,450 units

Firm Location

tyrone, PA

Reason for Recall

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

Distribution

US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.

Lot / Code Info

All lots: UL-AG-2110-05-Q UL-AG-2111-02-Q UL-AG-2112-01-Q UL-AG-2112-02-Q UL-AG-2201-03-Q

Root Cause

No Marketing Application

Action Taken

The firm initially contacted affected customers by phone between March 4 and March 12, 2022. On March 21, 2022, the firm followed up with emails to each affected distributor with subject line "IMPORTANT!!! Recall Notice" which included a recall letter attachment. Customers were asked to immediately return all unused product. The firm sent an additional email on March 25, 2022 which instructed customers to not rely on the recalled tests to make medical decisions. As of April 9, 2022, the full recall notice can be found at www.smldistribution.com.