Events

Recall of ThinPrep 5000 Processor with Autoloader

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hologic 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-00516-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00516-1
  • 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
    An investigation of customer complaints has determined that in rare cases, it is possible for the thinprep 5000 processor with autoloader to misread the value encoded in the vial barcode label. this occurs when the barcode scanner decodes a value that meets all symbology rules and check-digit validation but is not the intended value encoded in the barcode and processes the vial using this identifier. this potential is only present in thinprep 5000 processor with autoloader configurations and is not present in the benchtop configuration. in an autoloader configuration, if a misread occurs, the misread vial id value is transferred to the slide and a slide is produced with the incorrect identifier. there is a risk of misidentification of a patient slide.
  • Action
    Hologic is advising users to ensure the labels are graded against the appropriate standard. The Technical Information Reference Guide has been updates to clarify the barcode quality and specification requirements. Hologic is providing users with a software update to perform additional safety reads to improve identification of inadequate labels. Hologic is also providing users with updated barcode scanners. This action has been closed out on 19/01/2016.

Device

ThinPrep 5000 Processor with Autoloader

Manufacturer

Hologic Australia Pty Ltd