Events

Recall of Combur-Test and ChoiceLine 10 test kits (urine test strips). 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 Roche Diagnostics Australia Pty Limited.

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-2016-RN-01198-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01198-1
  • 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
    The instructions for use (ifu) contain an error regarding gram-status of bacteria for the nitrite test. in the limitations or accuracy section, gram-negative bacteria have been incorrectly referred to as gram-positive. however, the strip performance is not affected, so the product can still be used as specified. if a physician is not aware that a positive nitrite result is indicative of gram-negative bacteria, but follows the incorrect classification within the ifu, an insufficient class of antibiotic may be chosen for the initial treatment of urinary tract infection (uti). however, the “gram-classification” of bacteria should be common medical knowledge and use of recommended processes for identification of uti-causing bacteria (such as urine culture methods) will mitigate risk. nevertheless, a medical risk for patients due to an insufficient antibiotic chosen initially cannot entirely be excluded.
  • Action
    Roche is advising users of the correct wording for the Instructions for Use (IFU). A revised IFU will be provided to users, and additional information provided with each lot of product until the IFU is corrected. This action has been closed-out on 18/05/2017.

Device

Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical devic...
  • Model / Serial
    Combur-Test and ChoiceLine 10 test kits (urine test strips). An in vitro diagnostic medical device (IVD) ChoiceLine 10 testMaterial Number: 03504379023Combur10 Test UXMaterial Number: 11544373049Combur10 TestMaterial Number: 04510089056 Combur9 TestMaterial Number: 04510054056All lots affectedARTG Number: 224003
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited