Home / Recalls / Lusys Laboratories, Inc. / Z-1329-2015

Z-1329-2015 Class I Terminated

Recalled by Lusys Laboratories, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
April 15, 2015
Initiation Date
March 13, 2015
Termination Date
May 31, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,015 units

Product Description

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.

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.

Distribution Pattern

Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

Code Information

Lot No. 12012014B

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  • Z-1331-2015 Class I — Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus tes (March 13, 2015)
  • Z-1333-2015 Class I — Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Tes (March 13, 2015)
  • Z-1332-2015 Class I — Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus (March 13, 2015)