Events

Field Safety Notices about ARCHITECT STAT High Sensitive Troponin-I Calibrators, LN 3P25-01 and ARCHITECT STAT High Sensitive Troponin-I Controls, LN 3P25-10

According to Danish Medicines Agency, this field safety notices involved a device in Denmark that was produced by Abbott Diagnostics.

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.

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Device

ARCHITECT STAT High Sensitive Troponin-I Calibrators, LN 3P25-01 and ARCHITECT STAT High Sensitiv...

Manufacturer

Abbott Diagnostics
  • 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
    DMA