The United States Food and Drug Administration (FDA) has issued medical device safety alerts concerning various Ebola Virus One Step Test Kits, manufactured by LuSys Laboratories, Inc. The affected devices are identified as follow:-

• Ebola Virus Antigen Blood, Catalog No. I-123 (A).
• Ebola Virus GP-VP IgS, Catalog No. I-124.
• Ebola Accessories assembled, self-contained package, Catalog No. I-104. [Lot No. DEI007963]
• Ebola Virus Antigen Nasal , Catalog No. I-123 (B). [Lot No. 12292014B]
• Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100. [Lot No. 12012014B]
• Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101. [Lot No. 12012014B]
• Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103. [Lot No. 12012014A]
• Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102.[Lot No. 11192014B]

The manufacturer is recalling the above Ebola virus test kits as they have not yet been cleared, approved or authorised by the FDA for diagnostics purposes.

For details, please refer to the FDA website:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=70668&w=04152015%E2%8C%A9=eng

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 17 April 2015