Events

Recall of Device Recall Remel Middlebrook 7H10 Agar

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
    52111
  • Event Risk Class
    Class 3
  • Event Number
    Z-1733-2009
  • Event Initiated Date
    2009-05-06
  • Event Date Posted
    2009-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82111
  • 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
    Mycobacteria Identification Kit - Product Code JSY
  • Reason
    The plate labeling is incorrect, but the outer box labeling is correct.
  • Action
    The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.

Device

Device Recall Remel Middlebrook 7H10 Agar
  • Model / Serial
    Lot 763654, Exp. 2009.07.07
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.
  • Product Description
    Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. || Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.
  • Manufacturer
    Remel, Inc

Manufacturer

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