Events

Recall of Device Recall AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advandx 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
    68774
  • Event Risk Class
    Class 2
  • Event Number
    Z-2138-2014
  • Event Initiated Date
    2014-07-04
  • Event Date Posted
    2014-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128635
  • 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
    Fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, staphylococcus aureus - Product Code NXX
  • Reason
    Positive result in the internal negative control well for the staphylococcus quickfish bc test, failing qc.
  • Action
    AdvanDx notified customers by e-mail on July 4, 2014 of the problem and advised to discontinue use of the QuickFISH Fixation Kits with Lot#04914. Replacement kits were immediately shipped to all of the affected customers. Questions contact local AdvanDx representative or Technical Support 1-866-376-0009, fax 1-781-376-0111 or e-mail: techsupport@advandx.com. An acknowledgement of Receipt and Destruction of Materials requested to be completed.

Device

Device Recall AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures)
  • Model / Serial
    Lot Number: 04914 Exp. Date: 2015-06
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
  • Product Description
    AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test || Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
  • Manufacturer
    Advandx Inc

Manufacturer

Advandx Inc
  • Manufacturer Address
    Advandx Inc, 400 Tradecenter, Ste 6990, Woburn MA 01801
  • Manufacturer Parent Company (2017)
    Advandx, Inc.
  • Source
    USFDA