Events

Recall of MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    141326
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Customers reported receiving lhb broth tubes which visually appeared to be discolored and/or turbid. some of the tubes visually evaluated were confirmed to have been contaminated. the supplier performed retention samples testing for the two affected lots and found no contamination or turbid broth in any of the tubes however beckman coulter is sending notification letters to customers who received affected lots for their awareness. if a contaminated tube were inadvertently used it could result in mis-interpretation of susceptibility.

Device

MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH)
  • Model / Serial
    Model Catalog: B1015-25 (Lot serial: 1003705450); Model Catalog: B1015-25 (Lot serial: 1003730240)
  • Product Description
    MICROSCAN MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.