Events

Field Safety Notices about 595027 and 595029 series of access cea reagent kits used in the access immunochemistry family

According to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, this field safety notices involved a device in Poland that was produced by Beckman Coulter.

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
  • Event ID
    2347
  • Date
    2015-10-28
  • Event Country
    Poland
  • Event Source
    ORMPMDBP
  • Event Source URL
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-beckman-coulter-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania-serii-595027-i
  • Notes / Alerts
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Extra notes in the data
  • Action
    Beckman Coulter's safety notice regarding the recall and use of 595027 and 595029 series of Access CEA reagents used in the Access Immunochemistry family

Device

595027 and 595029 series of access cea reagent kits used in the access immunochemistry family

Manufacturer

Beckman Coulter