Events

Field Safety Notices about COULTER LH 750 Analyzer and others

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 Beckman Coulter, Inc. .

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
    2017-06-20
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • 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
    Beckman coulter has determined that additional clarification for the blast suspect messages is necessary. in rare situations, the lh 750, lh 780, lh 500 and hmx analyzers may not flag or detect blasts in some blood samples. this is due to limitations in the available technology as well as the properties of blasts in certain samples. .

Device

COULTER LH 750 Analyzer and others
  • Model / Serial
    COULTER LH 750 Analyzer 6605632, A85570, A68807 COULTER LH 780 Analyzer 723585, A90728, A68808 COULTER LH500 Analyzer 178832, 178833, 178834, A91062, A90994 COULTER HmX CP Analyzers 6605522, 6605523, 6605524 COULTER HmX AL Analyzers 6605525, 6605526, 6605527, A85566, A85564
  • Manufacturer
    Beckman Coulter, Inc.

Manufacturer

Beckman Coulter, Inc.