A recall was issued for sure COVID-19 antigen speedy assessments by Skippack Medical Lab for not being licensed for distribution within the U.S.
The Class 1 device recall for Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) is because of it being “distributed without FDA authorization or clearance for marketing and distribution in the US,” in response to the FDA.
The assessments might also be referred to as Skippack Medical Lab SARS-CoV-2 Antigen Speedy Check Equipment, Lateral Movement COVID 19 Speedy Antigen Check, SKIPPACK COVID-19 Antigen House Check, in response 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.”
According to Skippack Medical Lab, the numerous the impacted speedy assessments, their manufacturing and expiration dates:
The assessments had been distributed for nationwide use in New York, Alabama, Florida, Georgia, Texas and Wyoming.
In accordance with the FDA, the corporate initially contacted clients who could have been impacted by the recall by telephone between March 4 and March 12. Subsequently, on March 21, the agency adopted up with emails to every affected distributor with topic line “IMPORTANT!!! Recall Notice” and a recall letter attachment.
Clients had been requested by the corporate to instantly return all unused product, and had been despatched one other e mail on March 25 which instructed them to not depend on the recalled assessments for medical selections, the FDA mentioned.
Subsequent steps to take if take a look at was used
The FDA recommends sure steps to take:
- Check customers and caregivers ought to speak to their well being care supplier in the event that they examined with the Skippack Medical Lab SARS-CoV-2 Antigen Speedy Check (Colloidal Gold) and you’ve got issues about take a look at outcomes.
- Well being care personnel are suggested by the FDA to rethink testing sufferers with an FDA-authorized take a look at in the event that they had been initially examined with the Skippack Medical Lab SARS-CoV-2 Antigen Speedy Check (Colloidal Gold) within the final 2 weeks and you watched an inaccurate end result. If testing was carried out greater than two weeks in the past, and there’s no cause to suspect a present COVID-19 an infection, retesting just isn’t vital.
- Clients with questions concerning the recall can contact SML Distribution LLC by e-mailing [email protected] or calling 888-209-4406.