Events

Recall of Injection Pipette

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by The Pipette Company 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-00170-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00170-1
  • 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 pipette company (tpc) has been made aware of a potential dimensional issue with the injection pipettes which may result in a narrow internal diameter (id) of the pipette tip. a narrow internal diameter, below the acceptance criteria, may cause technical difficulties, including aspiration of sperm as sperm cannot be loaded into an overly narrow injection pipettes.
  • Action
    The Pipette Company is advising affected customers to complete the reply form supplied with the Customer Letter to schedule refund or exchange.

Device

Injection Pipette
  • Model / Serial
    Injection PipettePart Number: LICR-0D5Multiple Affected Lot NumbersManufacturing dates: May 2017-October 2017ARTG Number: 160455(The Pipette Company Pty Ltd - Micropipette, user-induced)
  • Manufacturer
    The Pipette Company Pty Ltd

Manufacturer

The Pipette Company Pty Ltd