Events

Safety Alert for Muller Hinton 2 agar + 5% sheep blood

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BioMerieux.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-08-18
  • Event Date Posted
    2016-08-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_201608018.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biomerieux muller hinton 2 agar + 5% sheep blood medical device manufacturer, biomerieux, has issued a medical device safety alert concerning its muller hinton 2 agar + 5% sheep blood [reference number: 43329, 43321 and 43324]. during an internal investigation, the manufacturer observed that the use of the medium mueller hinton 2 agar + 5% sheep blood (mh-s) (ref. 43329-43321-43324) with the cotrimoxazole antibiotic (= trimethoprime-sulfamethoxazole) (sxt) could lead to false susceptible results for s. pneumonia and streptococci strains with a disc diffusion method whatever is the shelf-life of the media. according to the manufacturer, results for others combinations strains-antibiotics that could be tested on mh-s medium (ref. 43321-43329-43324) are conform to the expected results. results on (mh2-f) (ref. 41864) bottle and mueller hinton 2 agar (mh2-d) (ref. 51075-51860) regarding the sxt antibiotic are conform to the expected results the manufacturer is advising users do not use the affected products with the sxt antibiotic whatever the strain that could be tested. the users can use (mh2-f) (ref. 41864) bottle and mueller hinton 2 agar (mh2-d) (ref. 51075-51860) with 5% sheep blood with the sxt antibiotic as products performed within the specifications. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 august 2016.

Device

Muller Hinton 2 agar + 5% sheep blood
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMerieux Muller Hinton 2 agar + 5% sheep blood
  • Manufacturer
    BioMerieux

Manufacturer

BioMerieux