Events

Safety Alert for ADVIA CALIBRATOR E

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SIEMENS HEALTHCARE DIAGNOSTICS INC. || Importer: SIEMENS S.A..

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-010316
  • Event Number
    INVIMA 2007RD-0000562
  • Date
    2016-03-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • 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
    A positive bias of 17% is reported when using the calibrator e batches completed in 42 and a negative bias of 7% using the e calibrator batches finished in 43, with respect to the values generated in the master curve. dichossesgos only occur when using the advia centaurtestosterone test.

Device

ADVIA CALIBRATOR E
  • Model / Serial
    Reference: 10309079; SMN code: 04634452, lots: 7226A42, || 55811A42, 53650A42, 53624A42, 15612A43, 17909A43, || 22868A43, 45084A43. || R eference: 10321075; Code SMN 04634762, lots: 86344A42, || 55437A42, 54801A42, 53651A42, 53625A42, 15610A43, || 18375A43, 24990A43, 38988A43 || R eference: 10335532; SMN code: 04636889, lots: 91005A42, || 53698A42
  • Product Description
    REAGENTS, CONTROLS AND CALIBRATORS USED TO DETERMINE ANALYTS FROM DEMONSTRATES OF HUMAN ORIGIN
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC. || Importer: SIEMENS S.A.

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC. || Importer: SIEMENS S.A.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA