Events

Recall of Etest Ceftaroline (CPT32) US B100

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
    69579
  • Event Risk Class
    Class 3
  • Event Number
    Z-0233-2015
  • Event Initiated Date
    2014-10-16
  • Event Date Posted
    2014-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130986
  • 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
    The products have a wrong expiration date on their labeling, 5 years instead of 2 years.
  • Action
    Consignees of bioM¿rieux, impacted by the identified issue, were notified of the FSCA and corrective action (FSCA notification) electronically on October 16th, 2014. Additionally, the bioM¿rieux United States subsidiary notified US consignees of the FSCA notification via FedEx on October 23rd, 2014.

Device

Etest Ceftaroline (CPT32) US B100
  • Model / Serial
    Ref #537548, Lot #1003202820, Right Expiry date: 27-APR-2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and the states of AL, AK, AR, AZ, CA, CO, DE, FL, GA, IA, IN, KY, MA, MD, MI, MO, NC, NE, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and the countries of Australia, Austria, China, Czech Republic, France, Germany, India, Italy, Japan, Netherlands, Poland, Portugal, Switzerland, Sweden, Turkey, United Kingdom, Egypt, Pakistan, Slovenia and Uruguay.
  • Product Description
    Etest¿ Ceftaroline (CPT32) US B100. || Etest¿ (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria.
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux