International Medical Devices Database

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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Type of Event
Safety alert
Event ID
IRD-031215
Event Number
INVIMA 2008RD-0001032
Date
2015-12-18
Event Country
Colombia
Event Source
INVIMA
Event Source URL
https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=164
Notes / Alerts

Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
Ostase access gauges and qcaccess ostase quality control are not stable as foreseen on the expiry date stated on the product label.

Device

Access Ostase calibrators

Model / Serial
Access Gauges: Ref. 37305 and Lots: 528936 and 528938 || Access Ostase QC: Ref. 37309 and Lots: 528937 and 528939
Product Description
Calibration, control and determination of the related analytes in samples from the human organism.
Manufacturer
BECKMAN COULTER || Importer: ROCHEM BIOCARE COLOMBIA S.A

Manufacturer

BECKMAN COULTER || Importer: ROCHEM BIOCARE COLOMBIA S.A

Manufacturer Parent Company (2017)
Danaher Corporation
Source
NIDFSINVIMA

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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Safety Alert for Access Ostase calibrators

What is this?

Device

Access Ostase calibrators

Manufacturer

BECKMAN COULTER || Importer: ROCHEM BIOCARE COLOMBIA S.A