Events

Recall of COULTER ReticPrep Reagent Kit (used for reticulocyte counting). 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 Beckman Coulter 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-2016-RN-00151-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00151-1
  • 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
    Beckman coulter has received an increased number of customer complaints related to the inability to scan or manually enter the reticprep barcode label. the reticprep barcode label number 2 contains characters that are not recognised by the software ("+$$" instead of "22"), and due to this issue the system will not generate results.The reported issue may lead to a delay in test results reporting. however, it is unlikely to cause adverse health consequences.
  • Action
    Beckman Coulter is advising users to follow the IFU to manually enter barcode number 2 with "22" in place of "+$$" which is printed on the label.

Device

COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical de...
  • Model / Serial
    COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical device (IVD)Reference Number: 7546978 Lot Number: 108912K Expiry Date: 11/12/2016ARTG Number: 223049
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd