Events

Recall of illumipro10 Incubator/Reader

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
    68396
  • Event Risk Class
    Class 2
  • Event Number
    Z-1941-2014
  • Event Initiated Date
    2014-04-22
  • Event Date Posted
    2014-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127512
  • 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
    C. Difficile nucleic acid amplification test assay - Product Code OMN
  • Reason
    Illumipro-10 instruments may have block b chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
  • Action
    Meridian sent an Urgent Medical Device Recall letter dated April 25, 2014, 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 return their unit to Meridian Bioscience. Meridian's Technical Support Staff will call them directly to provide them with a return authorization number and instructions for decontaminating, packaging and shipping the unit. For additional information customers were instructed to call 800-343-3858 (North America or 513-271-3700 (Worldwide).

Device

illumipro10 Incubator/Reader
  • Model / Serial
    Serial Numbers: IP2669, IP2670, IP2671, IP2672, IP2673, IP2674, IP2675, IP2676, IP2677, IP2678, IP2680, IP2682, IP2683, IP2684, IP2685, IP2686, IP2687, IP2688, IP2689, IP2690, IP2691, IP2692, IP2693, IP2694, IP2695, IP2696, IP2697, IP2698, IP2699, IP2700, IP2701, IP2702, IP2703, IP2704, IP2705, IP2706.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia.
  • Product Description
    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. || The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
  • 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