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
2017-07-28
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
Bd has recently confirmed that the instructions for use (ifu) part number 23-5351-03, dated 6/2016, for the reagent lots listed in the product tables below, contains errors in table 2: representative reference intervals for bd multitest™ cd3/cd8/cd45/cd4 listed on page 22. product performance is not impacted. table 1 below illustrates the values currently listed in the ifu and the correct values. .

Device

BD Multitest™

Model / Serial
BD Multitest™ CD3/CD8/CD45/CD4 342417 13532 2018-11-30 18636 2017-12-31 29783 2019-03-31 33552 2018-10-30 40550 2019-01-31 70946 2019-03-31 09831 2017-10-31 20936 2018-02-28 25555 2018-06-30 31761 2018-03-31 31864 2017-07-31 51629 2017-08-31 51897 2018-05-31 84976 2018-07-31 94769 2017-09-30 BD Multitest™ CD3/CD8/CD45/CD4 with BD Trucount™ Tubes 342447 11816 2019-03-31 11819 2019-03-31 35773 2019-04-30 35775 2019-04-30 63687 2019-05-31 70875 2019-02-28 03951 2017-08-31 09823 2017-09-30 20649 2018-07-31 23539 2018-11-30 25563 2018-05-31 26584 2018-06-30 27802 2017-10-31 29704 2017-12-31 29705 2017-12-31 33569 2018-09-30 34537 2017-12-31 38857 2017-07-31 38858 2017-07-31 38864 2017-07-31 42504 2017-07-31 42517 2018-09-30 43620 2018-07-31 45543 2018-02-28 50963 2018-07-31 53847 2017-12-31 53862 2017-12-31 55701 2018-02-28 57694 2018-07-31 60147 2017-10-31 60974 2017-10-31 61386 2018-03-31 71855 2017-08-31 81744 2018-03-31 81755 2018-03-31 81769 2017-12-31 87604 2018-07-31 87798 2017-08-31 90737 2017-12-31 93727 2018-03-31
Manufacturer
Becton Dickinson France S.A.S.

Manufacturer

Becton Dickinson France S.A.S.

Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
AMPMDRS

About this database

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 BD Multitest™

What is this?

Device

BD Multitest™

Manufacturer

Becton Dickinson France S.A.S.