Events

Safety Alert for chromID Strepto B Agar

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

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
    2012-10-31
  • Event Date Posted
    2012-10-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121031b.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 chromid strepto b agar the health canada posted a medical device safety alert concerning chromid strepto b agar [ref. no.: 43461; lot 1001508710; expiry date: 30 october 2012] manufactured by biomerieux sa. biomerieux could not guarantee the characteristic coloration of the streptococcus b colonies at 24 hours and 48 hours of incubation. false negative results could lead to incorrect diagnostic resulting to a serious deterioration in state of health of patients. according to the local supplier, the affected products were distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2012.

Device

chromID Strepto B Agar
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biomerieux chromID Strepto B Agar
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA