FDAClass IApril 15, 2015

Ebola Accessories assembled recall

Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

Why was Ebola Accessories assembled 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.

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?

Lot No. DEI007963

Product
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
Recalling firm
Lusys Laboratories, Inc.
Quantity
20 units
Distribution
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Recall date
April 15, 2015
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls