COVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization
SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per regulatory classification. The product lacks FDA authorization or clearance, meaning its diagnostic accuracy is unverified. No illnesses or injuries have been reported from the product distribution.
Plain-English summary
SML Distribution is recalling 209,450 units of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit, a COVID-19 rapid diagnostic test.
The product was distributed without FDA authorization or clearance for marketing and distribution in the United States. The product's performance and accuracy have not been verified by the FDA, which is why this is classified as an FDA Class I recall.
The affected test kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming. All lot codes are affected: UL-AG-2110-05-Q, UL-AG-2111-02-Q, UL-AG-2112-01-Q, UL-AG-2112-02-Q, and UL-AG-2201-03-Q.
Consumers who purchased or used these test kits should discontinue use. Anyone who relied on these kits for COVID-19 diagnosis should consult a healthcare provider about the reliability of their results.
The recalled product
- Product
- Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
- Manufacturer
- SML Distribution, LLC
- Category
- Medical Device
- Affected units
- 209,450
Distribution
Related recalls
Same hazard · unauthorized device
See all →- ModerateDVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization
FDA (Devices) · 2024-10-09
- HighRoyalVibe Unapproved Medical Devices Recalled Due to Lack of FDA Authorization
FDA (Devices) · 2023-10-18
- SevereFDA Recalls COVID-19 Antibody Test Kits for Lacking Regulatory Authorization
FDA (Devices) · 2022-03-16
- SevereLuscient Diagnostics COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization
FDA (Devices) · 2022-03-16
- SevereFDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
FDA (Devices) · 2022-02-16