Field Safety Notices about CELL-DYN Emerald Cleaner

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Abbott Laboratories.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The purpose of this letter is to inform you of a product recall for cell-dyn emerald cleaner lots 6991, 7024 and 7027, and to provide you with instructions on what actions your laboratory must take. abbott previously identified occurrences where the cell-dyn emerald analyzer generates quality control (qc) out of range low for parameters rbc and plt when using emerald cleaner lots 6853, 6901, and 6953. further investigation identified additional lots 6991, 7024, and 7027 as having similar occurrences. abbott is continuing to investigate but immediate actions are necessary. .


  • Model / Serial
    09H46-02 6991 30NOV2017 N/A 09H46-02 7024 31DEC2017 N/A 09H46-02 7027 31DEC2017 N/A
  • 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