Events

Recall of ZYM B REAGENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

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
    40899
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-23
  • 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
    Based on discrepant results (false negative results) reported from the field biomerieux initiated a complaint investigation. a loss of performance due to light exposure after 3 months of shelf life for api zym b which lead to false negative results on some api strips using the zym b (api 20 strep-20600 api coryne-20900 api staph-20500 api zym-25200 api nh-10400 api listeria-10300).

Device

ZYM B REAGENT
  • Model / Serial
    Model Catalog: 70493 (Lot serial: 1004355730); Model Catalog: 70493 (Lot serial: 1004097610); Model Catalog: 70493 (Lot serial: 1003787970); Model Catalog: 70493 (Lot serial: 1004077210); Model Catalog: 70493 (Lot serial: 1003765610); Model Catalog: 70493 (Lot serial: 1004355410); Model Catalog: 70493 (Lot serial: 1003772470); Model Catalog: 70493 (Lot serial: 1003772410); Model Catalog: 70493 (Lot serial: 1003790030)
  • Product Description
    ZYM B REAGENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.