Recall of Vacuette Minicollect Complete 1mL Sodium Citrate 3.2%.An in vitro medical device.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Interpath Services 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-2017-RN-01505-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-14
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    Interpath have become aware of an issue regarding inconsistent volumes of citrate present in a certain batch of the vacuette minicollect complete 1ml sodium citrate 3.2% tubes which may affect patient results.
  • Action
    Interpath is advising customers to inspect stock and quarantine all tubes of batch A17083KP. Customers should then complete the reply form provided with the Customer Letter so Interpath may arrange for stock to be recovered and replacement stock issued.

Device

  • Model / Serial
    Vacuette Minicollect Complete 1mL Sodium Citrate 3.2%.An in vitro medical device.Item Number: 450556Batch Number: A17083KPARTG: 256074
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    DHTGA