Events

Safety Alert for ZYM B reagent, API Listeria & API NH

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

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
    2013-11-18
  • Event Date Posted
    2013-11-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131118.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: biomérieux zym b reagent, api listeria & api nh medical device manufacturer, biomérieux inc has issued a medical device safety alert concerning zym b reagent (ref.:70493), api listeria (ref.: 10300) and api nh (ref.: 10400). biomérieux identified a visual defect and activity issue on the zym b reagent. the investigations performed by biomérieux’s quality control laboratory confirmed an activity issue on zym b reagent whatever the color of zym b ampule. this activity issue leads to a false negative result of some api biochemical tests using the zym b reagent. biomérieux explains that zym b reagent is used as an additional test for revealing the results of some miniaturized biochemical tests included in api 20 strep (20600), api coryne (20900), api staph (20500) and api zym (25200). the zym b reagent is also included in api nh (10400) and api listeria (10300). the manufacturer provides the following recommendations to the affected users: for zym b (70493), api nh (10400) and api listeria (10300) with zym b ampules having a visual defect (color not conform as described in the package insert), users are advised to destroy the kits and request product replacement. for zym b kits, api nh kits and api listeria kits without visual defect, users are advised to either use them according to instructions given in the safety alert or discard them and request replacement kits. users should discuss with their laboratory director to evaluate the impact and determine if retrospective analysis of results are required. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 november 2013.

Device

ZYM B reagent, API Listeria & API NH
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioMérieux ZYM B reagent, API Listeria & API NH
  • Manufacturer
    BioMérieux Inc

Manufacturer

BioMérieux Inc