Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
Reported: April 15, 2015 Initiated: March 13, 2015 #Z-1332-2015
Product Description
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
Reason for Recall
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.
Details
- Recalling Firm
- Lusys Laboratories, Inc.
- Units Affected
- 20 units
- Distribution
- Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit. Recalled by Lusys Laboratories, Inc.. Units affected: 20 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2015. Severity: Critical. Recall number: Z-1332-2015.
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