Events

Recall of Device Recall Great Basin Staph lD/R Blood Culture Panel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Great Basin Scientific, 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
    76076
  • Event Risk Class
    Class 2
  • Event Number
    Z-1051-2017
  • Event Initiated Date
    2016-12-12
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152100
  • 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
    Gram-positive bacteria and their resistance markers - Product Code PAM
  • Reason
    The great basin staph id/r panel is being recalled because the s. aureus probe could potentially result in a false positive.
  • Action
    The firm, Great Basin Scientific, notified customers by phone beginning on December 12, 2016 and by email on December 14 and 15, 2016. The notifications described the product, problem and actions to be taken. The customers were instructed to cease using and immediately discard all affected cartridges, the firm will replace those cartridges as soon as possible; and respond to the email or call Direct: 385.219.4540 or Support Team 888.333.9763 or email: customerssupport@gbscience.com with any questions or concerns.

Device

Device Recall Great Basin Staph lD/R Blood Culture Panel
  • Model / Serial
    Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Great Basin Staph lD/R Blood Culture Panel || The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
  • Manufacturer
    Great Basin Scientific, Inc.

Manufacturer

Great Basin Scientific, Inc.
  • Manufacturer Address
    Great Basin Scientific, Inc., 2441 S 3850 W, Salt Lake City UT 84120-7209
  • Manufacturer Parent Company (2017)
    Great Basin Scientific, Inc.
  • Source
    USFDA