Events

Recall of Hologic ThinPrep 5000 Processor with Autloloader (Instrument Analyser)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hologic Inc.

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
    20118
  • Event Initiated Date
    2016-05-04
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    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., 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.
  • Action
    Instructions for use to be updated

Device

Hologic ThinPrep 5000 Processor with Autloloader (Instrument Analyser)
  • Model / Serial
    Model: , Affected:
  • Manufacturer
    Hologic Inc

Manufacturer

Hologic Inc