Events

Recall of Premier EHEC Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Meridian Bioscience 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
    60124
  • Event Risk Class
    Class 2
  • Event Number
    Z-0203-2012
  • Event Initiated Date
    2011-10-10
  • Event Date Posted
    2011-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104483
  • 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
    Enzyme linked immunoasorbent assay, rubella - Product Code LFX
  • Reason
    Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. these false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.
  • Action
    Meridian Bioscience, Inc. sent an Urgent Medical Device Recall letter dated October 11, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop use of the affected product, evaluate testing performed with the affected product., and segregate and destroy remaining inventory. Customers were asked to contact Meridian's Technical Service Department by phone or facsimile as necessary. For replacement product phone 800-343-3858, outside North America 513-271-3700, Fax 513-272-5432. Customers were also asked to complete and return the attached Customer Response Form. In the event that they have no remaining inventory, customers were instructed to indicate such on the Customer Response Form and return to Meridian Technical Service. For questions phone 800-343-3858, outside North America 513-271-3700.

Device

Premier EHEC Kit
  • Model / Serial
    Lot# 608096, Lot# 8602 EXP.1, Lot# 2607 EXP.2, Lot# 8603 EXP.3, Lot# 8604 EXP.4, Lot# 1601 EXP.5, Lot# 1601 EXP.6, Lot# 8601 EXP.7, Lot# 1603 EXP.8
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI and WV and the countries of AUSTRALIA, CANADA, CHILE, COSTA RICA, ITALY, JAPAN and NEW ZEALAND.
  • Product Description
    EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealers || The Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II ( verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections.
  • Manufacturer
    Meridian Bioscience Inc

Manufacturer

Meridian Bioscience Inc
  • Manufacturer Address
    Meridian Bioscience Inc, 3471 River Hills Dr, Cincinnati OH 45244-3023
  • Manufacturer Parent Company (2017)
    Meridian Bioscience, Inc.
  • Source
    USFDA