COVID-19 antigen rapid tests recall: Reason, affected models, and all you need to know

Over 56,000 units of COVID-19 testing kits made by Universal Meditech Inc. are being recalled over violative distribution concerns. The voluntary recall affects the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits that were distributed in the market without receiving the appropriate premarket clearance and approval.

Universal Meditech Inc. initiated the nationwide voluntary recall right after it was informed by the FDA about the violative distribution of the unapproved Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. SML Distribution, LLC had earlier issued a 'Class one' device recall for similar test kit devices in 2022.

As of now, neither the FDA nor the manufacturer have received reports of any injury or other issues caused in regards to the usage of the recalled COVID-19 antigen rapid test kits.

The recalled Skippack Medical Lab ''Purple and white box'' under “Skippack Medical Lab” brand SARS-CoV-2 Antigen Rapid Test Kits (Image via FDA)

All similar test kits and devices must undergo a range of quality tests, premarket evaluations, and approvals by the FDA. Once approved, the devices can then be distributed through the retail channels for use by end-users and health professionals. Devices that fail to meet the set standards during the evaluation process are often deemed unfit for public usage and sent back.

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Universal Meditech initiated a nationwide recall of the COVID-19 antigen rapid test kits after it was unapproved by the FDA

The recalled 'DiagnosUS' brand "Green and white box" of SARS-CoV-2 Antigen Rapid Test Kits (Image via FDA)

The United States Food and Drug Administration (FDA) fears that the recalled COVID-19 antigen rapid test kits can give inaccurate or false test results due to the lack of performance evaluation.

As of now, the recall affects nearly 56,300 units of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits that are packed in labeled boxes. Manufactured between October 2021 and December 2021, the recalled COVID-19 test devices were distributed to retail channels in January 2022. The company distributed the recalled test kits to distributors in the states of California and Texas.

Customers could have bought the recalled COVID-19 kits from multiple retailers and pharmacists across the state or online. The 'Cassete' model test kits were distributed under the product label "Skippack Medical Lab," which comes in three different packaging boxes and includes:

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

The recalled COVID-19 kits that are distributed in ''White Box Without Brand Name" (Image via FDA)

Customers who may have bought the recalled Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits are strictly advised to refrain from using the devices anymore. Moreover, they should also contact the distributor for product returns. The company has already started notifying all known distributors and customers via phone and email. They are also arranging for proper returns of the recalled devices.

Customers who may have doubts or queries regarding the recall can get in touch with the Universal Meditech legal attorney via telephone at +1(702)871-9888, Monday to Friday, 9 am to 5 pm PST. The attorney can also be reached via email at [email protected].