Events

Recall of ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)

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-2018-RN-00090-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00090-1
  • 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
    Following a study conducted on etest polymyxin b with 180 clinical strains (pseudomonas aeruginosa, acinetobacter and enterobacteriaceae), an underestimation of mics has been observed for pseudomonas aeruginosa and acinetobacter species, compared to those obtained using the broth micro-dilution (bmd) reference method. this has led to false susceptible results when the etest polymyxin b results are interpreted using clsi breakpoints; there are no breakpoints for this drug in the eucast guidelines. as a consequence, etest polymyxin b (ref. 533400 & 533408) blister packaging can no longer be recommended for use with pseudomonas aeruginosa or acinetobacter strains.
  • Action
    bioMérieux is advising customers to discontinue use of the ETEST Polymyxin B strips to determine the MICs for Pseudomonas aeruginosa or Acinetobacter species. Laboratories can continue to use ETEST Polymyxin B for Enterobacteriaceae species.

Device

ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)
  • Model / Serial
    ETEST Polymyxin B (PO1024) blister packaging. (An in vitro diagnostic medical device)POLYMYXIN B PO 1024 WW B30 Reference Number: 533400Batch Numbers: 1005807890, 100575830, 1005497750, 1005161530, 1004414690POLYMYXIN B PO 1024 WW B100Reference Number: 533408Batch Number: 1004530070ARTG Number: 187139 (Biomerieux Australia Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd