Events

Safety Alert for Technical Name: PARAMETERS COMBINED ON THE SAME PRODUCT - CLASS II ANVISA Registration Number: 10345160165 Hazard Class: II Affected Model: Commercial presentations of 2 vials of high calibrator and low calibrator (Calibrator A) Advia Centaur, ACS: 180 Systems 5.0mL / unit) and 6 bottles of high calibrator and low calibrator (5.0mL / unit). Serial numbers affected: 07996A90; 21172A90; 27221A90; 43871A90; 44366A90

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics 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
    2169
  • Date
    2017-02-09
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Customers using the FT4 assay on the ADVIA Centaur, ADVIA Centaur XP & ADVIA Centaur XPT systems should discontinue use of the field affected lots for the FT4 assay. For the performance of this test, batch calibrators of numbering greater than the affected lot should be used. Customers can continue to use the affected Calibrator A batches for the Free T3 (FT3), Total T3 (T3), Total T4 (T4) and T uptake (Tup) assays for the ADVIA Centaur systems. Customers using the FT4 assay on the ADVIA Centaur CP system can continue to use all available Calibrator A batches. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Reason
    Siemens healthcare diagnostics has confirmed a negative bias for advia centaur free t4 (ft4) when using the a calibrator lots listed above on the advia centaur, advia centaur xp and advia centaur xpt systems. in addition, siemens healthcare diagnostics has confirmed a potential for calibration failures due to the% cvs of the calibrator rlus above the limit when using the calibrator a lots quoted above with the free t4 (ft4) assay. the performance of the free t4 assay (ft4) is not affected when the affected batches of the calibrator are used in the advia centaur cp system.
  • Action
    Field Action Code CC 17-04 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will make letter to the client.

Device

Technical Name: PARAMETERS COMBINED ON THE SAME PRODUCT - CLASS II ANVISA Registration Number: 10...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA