Events

Recall of Device Recall Remel MacConkey Agar w/Sorbitol

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
    37423
  • Event Risk Class
    Class 2
  • Event Number
    Z-0621-2007
  • Event Initiated Date
    2007-02-21
  • Event Date Posted
    2007-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50534
  • 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
    Agar - Product Code JSI
  • Reason
    False negative results for sorbitol fermenting bacteria such as e. coli 0157.
  • Action
    Recall letters dated 2/19/07 were issued on 2/21/07 via regular mail explaining the reason for recall and requesting all remaining inventory of the affected lot be discarded. A Product Inventory Checklist was enclosed to indicate the amount of inventory the customer discarded. This was to be returned via FAX or mail in the return envelope provided.

Device

Device Recall Remel MacConkey Agar w/Sorbitol
  • Model / Serial
    Lot 506069, Exp. 2007/03/20
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.
  • Manufacturer
    Remel, Inc.

Manufacturer

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