FDAFDA · Food and drugs·Recall number Z-1335-2015
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
Published April 15, 2015 · Recall initiated: March 13, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lusys Laboratories, Inc.
- Distributor
- Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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