International Medical Devices Database

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
2016-03-24
Event Date Posted
2016-04-20
Event Country
Serbia
Event Source
ALIMSA
Event Source URL
https://www.alims.gov.rs/latin/2016/04/20/proizvodac-clinical-diagnostic-solutions-1800-nw-65th-ave-fl-33313-plantation-sad-izdao-je-obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-cell-dyn-emerald-cleaner-hematolo/
Notes / Alerts

Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
Extra notes in the data
Reason
The manufacturer has determined that the cell-dyn emerald analyzer in some cases reports that the quality control results for the parameters "rbc" (erythrocytes) and "plt" (platelets) are outside the lower range.

Device

CELL-DYN Emerald CLEANER

Model / Serial
6853, 6901, 6953
Manufacturer
Abbott Laboratories

Manufacturer

Abbott Laboratories

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
ALIMSA

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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about CELL-DYN Emerald CLEANER

What is this?

Device

CELL-DYN Emerald CLEANER

Manufacturer

Abbott Laboratories