Skippack Medical Lab has issued an immediate recall of their SARS-CoV-2 (i.e. Coronavirus, Covid-19) Antigen Rapid Test Kits due to a lack of appropriate approval and clearance by the FDA which could result in inaccurate test results. All testing products must be pre-approved by the FDA prior to distribution to the public. In fact, this same test kit was recalled in March of 2022 under the same violation.
SUMMARY
Date of Recall:
Announced: February 9, 2023
Public Notification: February 10, 2023
Name(s) of Drug:
Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
Company Name:
Skippack Medical Lab
Distributed by: Universal Meditech Inc.
Drug Indication:
At home testing for Covid-19/Coronavirus.
Product Description
The tests were sold online and came with varying label styles. Some were distributed in purple and white boxes labeled with “Skippack Medical Lab.” Another variation was sold in blue and white boxes and labeled with “DiagnosUS.” A third variation was distributed in a plain white box without labeling.
Reason for Recall
No reports of injury have been noted at this time, but without prior approval by the FDA the testing kits are unable to be confirmed as accurate and reliable.
Impacts
Consumers utilizing the unapproved testing kits may receive incorrect results leading them to either believe they have Covid-19 when they do not, or leading to the spread of Covid-19 when they receive a faulty negative response. Other possible side-effects are still unknown at this time.
Lot information
This particular recall refers to all 56,300 tests from the company that were manufactured between October 2021 and December 2021 and were distributed in January of 2022.
Have you found that your test is part of the recall? Here’s what you should do:
Consumers
If you find that your tests are part of this recall, do the following:
- Do not use the tests.
- If you have already utilized the tests and are experiencing any symptoms of Covid-19, obtain a new test from your physician or pharmacy and re-test.
- Consumers who have not been contacted by the company can contact the company’s legal attorney at 1-702-871-9888. They are available Mon-Fri from 9:00am to 5:00pm (PST). You may also contact them via email at m@linlawgroup.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and/or assistance with disposing of all testing materials.
Retailer
- Examine all inventory and remove stock that is affected by the recall immediately.
- Retailers who have not been contacted by the company can contact the company’s legal attorney at 1-702-871-9888. They are available Mon-Fri from 9:00am to 5:00pm (PST). You may also contact them via email at m@linlawgroup.com.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled testing materials.
Wholesaler
- Examine all inventory and remove stock that is affected by the recall immediately.
- Wholesalers who have not been contacted by the company can contact the company’s legal attorney at 1-702-871-9888. They are available Mon-Fri from 9:00am to 5:00pm (PST). You can also contact them via email at m@linlawgroup.com.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and/or assistance with disposing of the recalled testing materials.
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