Events

Safety Alert for Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI ANVISA registration number: 10345160303; 10345161868 Affected Model: MAMMOMAT Inspiration

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
    2281
  • Date
    2017-04-28
  • 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
    Siemens does not recommend a review of previously generated results. ### 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 is making this notice available to communicate the restoration of the insulin (iri) trial advia centaur systems to the world health organization (who) 1st irp standard 66/304. siemens internal investigation has identified that the current batches of insulin systems advia centaur recover approximately 40% higher than the first world health organization (who) irp 66/304 standardization based on slope values. the slope value was observed at 1.40 on advia centaur xp and 1.42 on advia centaur cp. siemens confirmed that assay reportable range, reference range, precision, analytical sensitivity, accuracy, pro-zone effect and linearity were not impacted by this problem and continue to achieve the performance characteristics mentioned in the instruction of use (ifu). the investigations also concluded that the root cause of this problem is related to the raw material used during the production of the iri calibrators. this problem has been corrected and the standardization to the 1st irp 66/304 who has been restored starting with the iri advia centaur primer packs finished in 201 when paired with batches of iri caliper finished in 02, which will be available in may 2017.
  • Action
    Field Action Code CC 17-10 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: C...

Manufacturer

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