A recall was issued for certain COVID-19 antigen rapid tests by Skippack Medical Lab for not being authorized for distribution in the U.S.
The Class 1 device recall for Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) is due to it being "distributed without FDA authorization or clearance for marketing and distribution in the US," according to the FDA.
The tests may also be called Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home Test, according to the FDA.
"SML Distribution LLC is recalling these tests because these tests were distributed to U.S. customers without authorization, clearance or approval from the FDA," the agency said. "In addition, SML Distribution LLC did not provide the FDA with adequate validation data to show that the test’s performance is accurate. This means there is a risk of potential false negative, false positive, or misinterpretation of results."
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According to Skippack Medical Lab, the lots of the impacted rapid tests, their production and expiration dates:
| DATE: | LOT #: | EXPIRATION: |
| 1/5/2022 | UL-AG-2110-05-Q | 10/15/2023 |
| 1/10/2022 | UL-AG-2111-02-Q | 11/15/2023 |
| 1/18/2022 | UL-AG-2112-01-Q | 12/15/2023 |
| 1/19/2022 | UL-AG-2112-02-Q | 12/15/2023 |
| 2/1/2022 | UL-AG-2201-03-Q | 1/15/2024 |
The tests were distributed for nationwide use in New York, Alabama, Florida, Georgia, Texas and Wyoming.
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According to the FDA, the company initially contacted customers who may have been impacted by the recall by phone between March 4 and March 12. Subsequently, on March 21, the firm followed up with emails to each affected distributor with subject line "IMPORTANT!!! Recall Notice" and a recall letter attachment.
Customers were asked by the company to immediately return all unused product, and were sent another email on March 25 which instructed them to not rely on the recalled tests for medical decisions, the FDA said.
Next steps to take if test was used
The FDA recommends certain steps to take:
- Test users and caregivers should talk to their health care provider if they tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) and you have concerns about test results.
- Health care personnel are advised by the FDA to reconsider testing patients with an FDA-authorized test if they were initially tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) in the last 2 weeks and you suspect an inaccurate result. If testing was performed more than two weeks ago, and there is no reason to suspect a current COVID-19 infection, retesting is not necessary.
- Customers with questions about the recall can contact SML Distribution LLC by e-mailing techsupport@smldistribution.com or calling 888-209-4406.
