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U.S. Department of Health and Human Services

Class 1 Device Recall Skippack Medical Lab SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

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  Class 1 Device Recall Skippack Medical Lab SARSCoV2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test see related information
Date Initiated by Firm March 04, 2022
Create Date May 03, 2022
Recall Status1 Open3, Classified
Recall Number Z-0944-2022
Recall Event ID 89975
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Code Information 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
Recalling Firm/
SML Distribution, LLC
1500-1631 Lincoln Ave.
tyrone PA 16686
For Additional Information Contact Christopher Nagle
Manufacturer Reason
for Recall
The product was distributed without FDA authorization or clearance for marketing and distribution in the US.
FDA Determined
Cause 2
No Marketing Application
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.
Quantity in Commerce 209,450 units
Distribution US Nationwide distribution in the states of AL, FL, GA, MO, NY, TX, and WY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.