Events

Safety Alert for Capture R Ready ID

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by IMMUCOR || Importer: LABORATORIOS DAI DE COLOMBIA.

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
    IRD-010216
  • Event Number
    INVIMA 2014RD-0002919 ; INVIMA 2014RD-0002843
  • Date
    2016-02-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=157
  • 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
    Unexpected positive reactivity when testing n3512 donors with anti - v antibodies. initial research has confirmed that these donors are v +, so they will be classified as such in the update of the main list with the product.

Device

Capture R Ready ID
  • Model / Serial
    Capture-R® Ready ID® lot ID286 CEL # 11 || Capture-R® Ready ID® lot ID287 CEL # 12 || Panocell 20® Lot 47436 CEL # 18 || Panocell 16 ® Lot 39330 CEL # 6 || Panocell 20® Lot 23160 CEL # 16 || Panocell 20® Lot 14052 CEL # 18 || Capture-R® Ready ID® Extend II Lot DN074 CEL # 13
  • Product Description
    SOLID PHASE SYSTEM FOR THE IDENTIFICATION OF RARE ANTIBODIES IgG AGAINST ANTIGENOSERITROCITARIOS.INDICATED FOR THE IDENTIFICATION OF EXPECTED ANTIBODIES DIRECTED AGAINST GROUPS HANGINGS OF HEMATIES
  • Manufacturer
    IMMUCOR || Importer: LABORATORIOS DAI DE COLOMBIA

Manufacturer

IMMUCOR || Importer: LABORATORIOS DAI DE COLOMBIA