Events

Safety Alert for pipettes for micromanipulation

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Origio Inc.

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.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1407-275
  • Event Number
    2013DM-0010658
  • Date
    2014-07-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=201
  • 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
    The manufacturer informs about the possible compromise of the sterile barrier of the device, leading to the potential occurrence of adverse events on the patient.

Device

pipettes for micromanipulation
  • Model / Serial
    PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL with expiration dates May 02, 2015 or later
  • Product Description
    These pipettes are used for Micromanipulation and cell, oocyte or blastocyst removal procedures
  • Manufacturer
    Origio Inc

Manufacturer

Origio Inc