Events

Safety Alert for Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high calibrator; 2 vials (5.0 mL / vial) of low calibrator. Kit containing: 6 vials (5.0 mL / vial) of high gauge; 6 vials (5.0 mL / vial) of low calibrator //// Registration: 10345160165, hazard class II. Affected lots: 40978A84; 41239A84; 41846A84; 44162A84; 47938A84; 51961A86; 53232A86; 55812A86; 95551A87; 07628A87; 18026A87.

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
    1720
  • Date
    2015-10-28
  • 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
    Siemes Healthcare identified that these observed differences would not affect patient diagnosis or monitoring, although failures in 1: 4 and 1: 8 dilution recoveries with Calibrator A could affect T4 accuracy levels above the assay range .
  • Reason
    Siemens healthcare diagnostics proactively conducted a customer notification regarding 1: 4 and 1: 8 manual dilution recovery in the advia centaur t4 assay, used in the advia centaur xp, advia centaur xp, advia centaur xp and advia centaur cp systems. siemens has identified that recovery percentages for dilutions of patient samples 1: 4 (with calibrator a prior to the batches terminated at 84 and 86) and 1: 8 (batches terminated at 84, 86 and 87) are lower than the advia centaur t4 instruction for use. (see attached).
  • Action
    Correction of Instructions for Use The company will: discontinue the use of 1: 8 manual sample dilutions of T4 samples on ADVIA Centaur systems. /// Manual dilutions 1: 2 and 1: 4 can be performed for T4 samples with results above the assay range for Batches of Calibrator A terminated at 87 and above. It was confirmed that these dilutions performed as expected. /// Batches of Calibrator A terminated at 84 and 86 may continue to be used for all other assays requiring Calibrator A, except for dilutions of T4 samples. (SEE ANNEX) .Code of Action: CN CC 15-14.

Device

Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high...

Manufacturer

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