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Open, Classified

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

FDA Recall Z-0944-2022 · Posted None

Recalling FirmSML Distribution, LLC
Recall StatusOpen, Classified
Product CodeQKP
Date Initiated2022-03-04
Product Quantity209,450 units

Reason for Recall

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

Firm Action

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.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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