Events

Recall of Device Recall Oxoid CM0225 Brain Heart Infusion IVD

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
    54194
  • Event Risk Class
    Class 2
  • Event Number
    Z-0979-2010
  • Event Initiated Date
    2009-12-21
  • Event Date Posted
    2010-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87805
  • 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
    Brain Heart Infusion IVD - Product Code JSC
  • Reason
    Product failure - failure to grow quality control strains of streptococcus pneumoniae.
  • Action
    The recalling firm issued separate recall letters dated December 21, 2009 addressed to Microbiology Laboratory Supervisors or Distributors explaining the reason for recall and requesting all remaining product be discarded. A Product Inventory Checklist was enclosed to report the amount of product that was discarded by the customer. The Distributor letter requests the consignee contact their customers to notify them of the recall. Direct inquiries concerning this recall to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).

Device

Device Recall Oxoid CM0225 Brain Heart Infusion IVD
  • Model / Serial
    Lot numbers 762134, Exp. 2014.04.30; 793640, Exp. 2014.07.31; and 819693, Exp. 2014.10.31
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    United States (FL, NY, MO, NY, DE, and PA).
  • Product Description
    Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. || The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work.
  • Manufacturer
    Remel, Inc

Manufacturer

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