Events

Recall of Device Recall Ebola VP40 IgG/IgM (Blood Serum/Plasma/Cassette),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lusys Laboratories, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70668
  • Event Risk Class
    Class 1
  • Event Number
    Z-1330-2015
  • Event Initiated Date
    2015-03-13
  • Event Date Posted
    2015-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134407
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    virus test kit - Product Code N/A
  • Reason
    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.
  • 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.

Device

Device Recall Ebola VP40 IgG/IgM (Blood Serum/Plasma/Cassette),
  • Model / Serial
    Lot No. 11192014B
  • Distribution
    Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
  • 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
  • Manufacturer
    Lusys Laboratories, Inc.

Manufacturer

Lusys Laboratories, Inc.
  • Manufacturer Address
    Lusys Laboratories, Inc., 10054 Mesa Ridge Ct Ste 118-120, San Diego CA 92121-2946
  • Manufacturer Parent Company (2017)
    Lusys Laboratories Inc
  • Source
    USFDA