Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT
Summary
The FDA issued a Class I for Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test K by Universal Meditech Inc.. Reason: Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization..
Details
Source
Device Recall
External ID
Z-0929-2023
Action Date
2023-02-08
Status
Ongoing
Category
device
Product Description
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Lot/Code Info: Model Number: 550-10 UDI Code: None Lot Numbers: UL-AG-2111-01-Q UL-AG-2111-02-Q UL-AG-2110-05-Q UL-AG-2112-02-Q UL-AG-2110-03-Q UL-AG-2110-04-Q
Quantity Affected: 56,300 kits
Reason for Recall
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Distribution
U.S. Nationwide distribution in the states of CA, and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-28
Company
Fresno, CA
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 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Universal Meditech Inc. has 28 FDA actions in our database, including 28 recalls.
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 (Universal Meditech Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Universal Meditech Inc. have FDA actions?
Universal Meditech Inc. has 28 FDA actions in our database, including 28 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0929-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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