Events

Recall of ERIC (Electronic RapID Compendium) Version 1.0.77

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel, 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
    53800
  • Event Risk Class
    Class 3
  • Event Number
    Z-0870-2010
  • Event Initiated Date
    2009-10-28
  • Event Date Posted
    2010-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86536
  • 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
    Kit, Identification, Yeast - Product Code JXB
  • Reason
    There is an error in version 1.0.77 of the electronic code compendium (eric) software. the error is limited to the database corresponding to the r8311007 rapid yeast plus system. the database erroneously includes candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between candida albicans and candida dubliniensis. when using the.
  • Action
    The firm issued an "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" dated October 29, 2009. After completion of the firm's investigation and risk assessment, Remel decided to notify customers of this situation and quarantine any remaining units on hand. The notification provided the consignees with instructions for obtaining and downloading the software patch. A response form was included with the recall letter and the consignee was asked to complete the form and return it to Remel. The consignees should contact the Technical Services Department at 800-255-6730 (USA) or 913-888-0939 (International), if they have inquiries concerning this advisory.

Device

ERIC (Electronic RapID Compendium) Version 1.0.77
  • Model / Serial
    ERIC (Electronic RapID Compendium) Version 1.0.77 -- Lot No. 0001096277
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Europe and Canada
  • Product Description
    ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of the organisms addressed by the RapID Yeast Plus System is given in the RapID Yeast Plus Differential Chart. || RapID" YEAST PLUS System, Catalog No. R8311007. 4 hour identification of yeast based on enzyme technology. Database includes over 40 taxa. Requires Inoculation Fluid, REF R8325106. CE, 20 Panels/Kit The responsible firm name on the product labeling is Remel, 12076 Santa Fe Dr., Lenexa, KS 66215-3594
  • Manufacturer
    Remel, Inc

Manufacturer

Remel, Inc
  • Manufacturer Address
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA