AntIbody to SARS-CoV-2 - Product Usage recall
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies…
Why was AntIbody to SARS-CoV-2 - Product Usage recalled?
Distributed COVID test kits without emergency use authorization.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2020042901
- 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…
- Recalling firm
- Sky Medical Supplies and Equipments LLC
- Quantity
- 10,000 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
- Recall date
- February 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)