Events

Recall of API ZYM B. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia Pty Ltd.

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
    RC-2015-RN-01270-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01270-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Based on discrepant results (false negative results) reported from the field, biomérieux initiated a complaint investigation to confirm product performance and determine root cause. the investigation confirmed a loss of performance after 3 months of shelf life for api zym b, which led to false negative results on some api strips using the zym b reagent. as a result of the zym b performance shift, the risk is to potentially report a false negative result of some api tests; misidentification of some species with api 20 strep, api nh, api listeria and api coryne. api staph is not impacted by a risk of misidentification. regarding api zym, as it is designed for the research of enzymatic activities, there is no risk of microorganism misidentification.
  • Action
    Biomerieux is advising users to perform quality control with ATCC strains prior to using the ZYM B ampule. A review of previously reported results is recommended at the discretion of the Laboratory Director.

Device

API ZYM B. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    API ZYM B. An in vitro diagnostic medical device (IVD)Product Code: 70493Multiple Lot numbers affectedARTG Number: 232822
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd