Events

Safety Alert for FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH

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
    2014-03-11
  • Event Date Posted
    2014-03-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140311.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 fb (fast blue bb), zym b reagent, api listeria, and api nh medical device manufacturer, biomerieux, has issued a field safety notice (fsn) concerning certain lots of biomerieux fb (fast blue bb) with reference number 70562, zym b reagent with reference number 70493, api listeria with reference number 10300, and api nh with reference number 10400. identification strips using the fb reagent: api campy (20800), id 32 staph (32500), rapid id 32a (32300), rapid id 32 strep (32600) identification strips using the zym b reagent: api 20 strep (20600), api coryne (20900), api staph (20500), api zym (25200), api nh (10400), api listeria (10300) the issue may result in misidentification of microorganisms. the manufacturer advises users of the followings: if users are in possession of some kits of fb reagent (70562), they should implement the mandatory requirements as mentioned in the fsn. if users are in possession of some kits of zym b (70493), api nh (10400) and api listeria (10300), they should check the aspect of zym b (70493) before each use and follow the recommendations mentioned in the fsn. users should discuss with the laboratory director to evaluate the impact and determine if any retrospective analysis of results is required. for the next batches, an insert will be added in fb reagent (70562), zym b (70493), api nh (10400) and api listeria (10300) to explain the mandatory actions required in this fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 march 2014.

Device

FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biomerieux FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
  • Manufacturer
    Biomerieux

Manufacturer

Biomerieux