Home / Recalls / Lusys Laboratories, Inc. / Z-1330-2015

Z-1330-2015 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
80 units

Product Description

Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged

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. 11192014B

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  • Z-1335-2015 Class I — Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit (March 13, 2015)
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  • Z-1334-2015 Class I — Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test (March 13, 2015)
  • Z-1328-2015 Class I — Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Prov (March 13, 2015)
  • Z-1329-2015 Class I — Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Prov (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)