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U.S. Department of Health and Human Services

Class 1 Device Recall Ebola GP IgX Blood, Serum, Plasma, Cassette

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  Class 1 Device Recall Ebola GP IgX Blood, Serum, Plasma, Cassette see related information
Date Initiated by Firm March 13, 2015
Date Posted April 09, 2015
Recall Status1 Terminated 3 on May 31, 2017
Recall Number Z-1329-2015
Recall Event ID 70668
Product Classification virus test kit - Product Code N/A
Product Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101

Materials Provided:
1. Test Device
2. Lancet (optional)
3. Alcohol pad. (optional)
4. Extraction tube (optional)
5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.

Code Information Lot No. 12012014B
Recalling Firm/
Lusys Laboratories, Inc.
10054 Mesa Ridge Ct Ste 118-120
San Diego CA 92121-2946
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
No Marketing Application
Action LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688. For questions regarding this recall call 858-546-0902.
Quantity in Commerce 1,015 units
Distribution Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.