Reported Feb 24, 2021 · Terminated
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole…
Sky Medical Supplies and Equipments LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sky Medical Supplies and Equipments LLC · 5987 Nw 102nd Ave · Doral, FL · 33178-2820
Is this the product you have?
- 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
- Lot codes and dates
- 2020042901
- Amount recalled
- 10,000 kits
Where it was sold
- Nationwide
- FL
Why it was recalled
Distributed COVID test kits without emergency use authorization.
This product could cause temporary or reversible health problems — stop using it.
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