Events

Recall of Device Recall Etest

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

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
    72755
  • Event Risk Class
    Class 1
  • Event Number
    Z-0439-2016
  • Event Initiated Date
    2015-11-19
  • Event Date Posted
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142156
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Reason
    Due to the potential for reporting erroneous results for piperacillin/tazobactam; specifically false susceptible results.
  • Action
    Consignees (Subsidiaries and Distributors) of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on November 24th, 2015. Additionally, the bioM¿rieux United States subsidiary notified US consignees (distributors/end-users) of the FSCA notification via FedEx on December 2nd, 2015.

Device

Device Recall Etest
  • Model / Serial
    Ref. 412434, Lot numbers: 1004331500, 1004271120, 1004178060, 1003977300, 1003697470, 1003415090, 1003276060, 1003069230, 1002488490 and  1001936360.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- US Nationwide including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GS, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV and WY, and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Japan, Kazakhstan, Kenya, Kingdom of Saudi Arabia, Kuwait, Lebanon, Lithuania, Malaysia, Macedonia, Oman, Netherlands, Pakistan, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Singapore, Slavonia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, the United Kingdom, Vietnam and Venezuela.
  • Product Description
    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW || Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux