Events

Safety Alert for COBAS B-123 POC SYSTEM analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Roche Diagnostics Gmbh || Roche Diagnostics International Ltd. || Roche Diagnostics Graz Gmbh.

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
    I1609-371
  • Event Number
    2011DM-0007372
  • Date
    2016-09-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=123
  • 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 states that it has detected the possibility of obtaining a measurement of low results in the total labilirubin value in samples of neonates analyzed by the referenced medical devices, leading to the presentation of possible adverse events on the patients.

Device

COBAS B-123 POC SYSTEM analyzer
  • Model / Serial
    Cobas b123, specific serials.
  • Product Description
    The COBAS B-123 POC SYSTEM analyzer <1, 2, 3 and 4> is an automated device for the quantitative determination of Ph, arterial gases and electrolytes by leaving in whole blood, serum, plasma or urine. It also performs debicarbonate, lactate, GLUCOS HCT and HB tests, depending on the final configuration of the instrument from VR1 to VR4. It is an automated system that reports the values of the tests and communicates the results of the patient's clinics. The instrument can be used in the critical care units (POINT-CARE) or in the clinical laboratory. The reagents used with the COBAS B-123 POC SYSTEM DE ROCHE analyzer system have respective health records.
  • Manufacturer
    Roche Diagnostics Gmbh || Roche Diagnostics International Ltd. || Roche Diagnostics Graz Gmbh

Manufacturer

Roche Diagnostics Gmbh || Roche Diagnostics International Ltd. || Roche Diagnostics Graz Gmbh