Events

Safety Alert for Dade Actin (Activated Cefaloplastin Reagent-APTT)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by DADE BEHRING INC. || Imported by: SIEMENS/VELEZLAB.

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
    RRD-050815
  • Event Number
    2006RD-0000164
  • Date
    2015-08-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=173
  • 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
    Cessation of the use of certain lots of the reagent because the recovery value of the control is outside the assigned ranges. a deviation of> 3 seconds has been observed for the normal aptt range and / or> 15% in the pathological range. samples of patients with recoveries to medical decision points may exhibit deviation of up to 4 seconds for the normal range and up to 33% for the pathological range.

Device

Dade Actin (Activated Cefaloplastin Reagent-APTT)
  • Model / Serial
    Reference B4218-1, Lot: 557115, 557115A, 557115B, || 557116, 557127, 557136, 557137, 557139, 557139A, || 557142, 557145, 557145A, 557146, 557150, 557151
  • Product Description
    Reagents, controls and calibrators used for the determination of analytes of the coagulation area in samples of human origin.
  • Manufacturer
    DADE BEHRING INC. || Imported by: SIEMENS/VELEZLAB

Manufacturer

DADE BEHRING INC. || Imported by: SIEMENS/VELEZLAB
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA