Events

Recall of Biokit and SureVue HSV2 Rapid Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biokit U.S.A. 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
    55316
  • Event Risk Class
    Class 2
  • Event Number
    Z-1970-2010
  • Event Initiated Date
    2010-04-14
  • Event Date Posted
    2010-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90535
  • 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
    Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
  • Reason
    Negative serum was giving a positive result herpes simplex type 2 (hsv-2). it is possible that misdiagnosis (i.E., positive) could be made.
  • Action
    Biokit USA notified US Customers by fax on 2/18/10 of the reason for the kit recall and requested to discard any remaining units. Accounts were advised to retest patients or review test results. Questions are directed to the firm at 800-926-3353.

Device

Biokit and SureVue HSV2 Rapid Test
  • Model / Serial
    Batch M691 (expiry: 2010/09) Batch M699 (expiry 2010/12)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
  • Product Description
    Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. || 20 test Kit || In Vitro Diagnostic test for Herpes Simplex Virus 2
  • Manufacturer
    Biokit U.S.A. Inc.

Manufacturer

Biokit U.S.A. Inc.
  • Manufacturer Address
    Biokit U.S.A. Inc., 180 Hartwell Rd, Bedford MA 01730-2443
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA