Events

Recall of Cobas b 101 HbA1c Test (used to test for diabetes)

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-2013-RN-00954-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00954-1
  • 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
    Detailed investigations have confirmed a deviation in the hba1c result in the range of -10% to up to -30% from the target value with an error rate of up to 40%.
  • Action
    Roche is requesting their customers to discard any affected HbA1c. Destroyed product will be replaced with new stock once it is available.

Device

Cobas b 101 HbA1c Test (used to test for diabetes)
  • Model / Serial
    Cobas b 101 HbA1c Test (used to test for diabetes)Material Number: 06378676190Lot Number : All lots (303022-01, 304021-01, 304022-01, 304023-01, 304024-01, 304025-01, 305021-01, 306022-01, 306023-01 & 307021-01) within shelf life are affectedSystem affected: Cobas b 101An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited