Sky Medical SARS-CoV-2 Rapid Test Kits Recalled for Lack of Emergency Use Authorization
Sky Medical Supplies and Equipments LLC is recalling 10,000 SARS-CoV-2 rapid test kits distributed in Florida and Peru because they were sold without FDA Emergency Use Authorization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is the lack of regulatory authorization (EUA) rather than a reported defect causing injury, fitting the Moderate category for regulatory compliance issues without reported harm.
Plain-English summary
Sky Medical Supplies and Equipments LLC is recalling 10,000 units of the Antibody to SARS-CoV-2 Rapid Test Device. The product is a colloidal gold diagnostic kit intended for use with whole blood, serum, or plasma to detect IgG and IgM antibodies. The recall is being conducted because the kits were distributed without an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.
The affected products were distributed worldwide, with specific distribution noted in the state of Florida in the United States and in the country of Peru. The recall code associated with this action is 2020042901.
Consumers who have purchased these test kits should stop using them immediately. The lack of an EUA means the product has not been authorized by the FDA for use in the United States, and its performance and safety have not been verified through the standard regulatory process for emergency use.
The recalled product
- Product
- AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.
- Manufacturer
- Sky Medical Supplies and Equipments LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- Affected units
- 10,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2020042901
Distribution
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