Events

Recall of PTS Panels CHOL+GLU 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 Point Of Care Diagnostics 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-00254-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00254-1
  • 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
    This recall is being conducted due to the potential for loss of activity of the glucose analyte prior to the full stated shelf life (august 2018).Based on the results of internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. this issue may result in the delay in diagnosis of diabetes. there have been no adverse events reported in conjunction with this product.
  • Action
    Point of Care Diagnostics (PTS) is advising users to inspect stock and quarantine any remaing kits of the affected lots. Affected stock is to be destroyed. PTS will issue replacement product or a credit note.

Device

PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)Reference Number: 1765Lot Number: A705 and A707Expiry Date: August 2018Unique Device Identification Code: Lot Numbers: A705: (01)00381931765016(17)180813(10)A705Lot Numbers: A707: (01)00381931765016(17)180828(10)A707ARTG Number: 252292(Point Of Care Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Point Of Care Diagnostics Australia Pty Ltd

Manufacturer

Point Of Care Diagnostics Australia Pty Ltd