Skippack Medical Lab is recalling certain lots of COVID-19 antigen rapid tests because they were never authorized for distribution.
Believe it or not, COVID-19 is still floating around out there, meaning people across the country are still relying on having access to reliable and safe testing options. Unfortunately, a recall was announced earlier this week for certain COVID-19 antigen rapid tests manufactured by Skippack Medical Lab. Why? Well, it turns out they were never properly authorized for distribution here in the U.S.
The FDA stated:
“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.”
The federal agency also noted that the tests might be available under the following names: “Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, Lateral Flow COVID 19 Rapid Antigen Test, SKIPPACK COVID-19 Antigen Home Test.” It further stated:
“SML Distribution LLC is recalling these tests because these tests were distributed to U.S. customers without authorization, clearance, or approval from the FDA…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.”
The recalled tests were distributed throughout New York, Alabama, Florida, Georgia, Texas, and Wyoming. At the moment, the following lots are included in the recall: