Safety Alert for Alinity i Processing Module

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: abbott alinity i processing module medical device manufacturer, abbott, has issued a medical device safety alert concerning its alinity i processing module [list number: 03r65, serial numbers: ai01001 to ai01336]. the manufacturer has identified an issue with the alinity i bulk solution dispense pumps (part number a‐35001280‐01) resulting in pump failures. the issue is linked to the design of an internal seal within the pump that allows a small amount of leakage of bulk solution. the failure of the pump could result in unexpected instrument down time potentially causing a delay in generating results. according to the manufacturer, the amount of the leakage does not impact the ability of the pump to accurately dispense bulk solutions, and the leakage is contained within the service‐only area of the instrument. therefore, the issue does not pose a risk of incorrect results nor a risk of physical exposure to the operator. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 sep 2018.


  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Alinity i Processing Module
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • 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