Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Summary
The FDA issued a Class I for Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 1 by SML Distribution, LLC. Reason: The product was distributed without FDA authorization or clearance for marketing and distribution in the US..
Details
Source
Device Recall
External ID
Z-0944-2022
Action Date
2022-05-11
Status
Ongoing
Category
device
Product Description
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
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
Quantity Affected: 209,450 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-04
Company
tyrone, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 121 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SML Distribution, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SML Distribution, LLC have FDA actions?
This is the only FDA action we have on record for SML Distribution, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0944-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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