Events

Recall of i-STAT Alinity Instrument i-STAT Alinity Analyzer Software

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Abbott Point of Care Canada 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
    22433
  • Event Initiated Date
    2018-01-12
  • 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: Abbott Australasia Pty Ltd (NZ), Abbott Laboratories NZ, 4 Pacific Rise, Mt Wellington, Auckland 1060
  • Reason
    Through a combination of internal studies and customer reports, the manufacturer has determined that the following may occure:, 1. an increased frequency of quality check failure code 90-02 when testing i-stat cartridges with the i-stat alinity software version osi05 (jams 79a / clew d34)., 2. when testing with i-stat cartridges that report ph, pco2 and po2, an i-stat alinity instrument with software version osi05 (jams 79a / clew d34) that is customized to correct for user entered patient temperature may report incorrect ph and/or pco2 results.
  • Action
    Software to be upgraded

Device

i-STAT Alinity Instrument i-STAT Alinity Analyzer Software

Manufacturer

Abbott Point of Care Canada Ltd
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA