Events

Recall of Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT Staph ID

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integrated Science Systems 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
    74140
  • Event Risk Class
    Class 2
  • Event Number
    Z-1911-2016
  • Event Initiated Date
    2016-02-19
  • Event Date Posted
    2016-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146458
  • 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
    Staphylococcus aureus protein a insoluble - Product Code LHJ
  • Reason
    Customer complaints of very weak reactions with the kit, or false negative results with different staph aureus cultures.
  • Action
    Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.

Device

Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT ...
  • Model / Serial
    Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to CA only.
  • Product Description
    Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T || The product is used as an aid in the identification of Staphylococcus aureus from Culture
  • Manufacturer
    Integrated Science Systems Inc

Manufacturer

Integrated Science Systems Inc
  • Manufacturer Address
    Integrated Science Systems Inc, 1215 George C Wilson Dr Unit A4, Augusta GA 30909-5700
  • Manufacturer Parent Company (2017)
    Integrated Science Systems Inc.
  • Source
    USFDA