Universal Meditech Recalls Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit


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Universal Meditech Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit


Universal Meditech Inc. has initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.

Consumers who have Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits should stop using the device immediately and contact the distributor for product return.


Recalled products were manufactured from October 2021 to December 2021 and distributed in January 2022.


The following styles/models/UDI have been recalled:

  • Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
  • UDI: None
  • Model: Cassette
  • Quantity: 56,300


Products were distributed with “Skippack Medical Lab” branded Instructions for Use leaflet in three different packaging boxes identified below:

  • Purple and white box under “Skippack Medical Lab” brand
  • Green and white box under “DiagnosUS” brand
  • White box without brand name


Universal Meditech Inc. voluntarily recalled the product after becoming aware of the violative distribution notified by the FDA.

To date, there has not been any reported injury.


Universal Meditech Inc. is notifying its distributors and customers by phone and email and is arranging for return of all recalled products.


Universal Meditech Inc. has distributed the products to distributors in California and Texas.

Source: FDA

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Consumer Contact: -

Consumers with questions may contact the legal attorney of the company via telephone at +1(702)871-9888 between the hours of 9AM and 5PM, P.S.T. Consumer may also contact the legal attorney of the company via e-mail at m@linlawgroup.com.

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A recall of the same device has been previously conducted by SML Distribution LLC, for which the details can be found at the link below:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=193010

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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

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Report a Problem With This Product

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

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You Are Leaving Us

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