Skippack COVID Antigen Test (SML Distribution) – Unauthorized Distribution (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Brand
SML Distribution, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
SML Distribution, LLC is recalling Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test due to The product was distributed without FDA authorization or clearance for marketing and distribution in the US.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026