Events

Safety Alert for 100 ml Test Kit - Pearls 100u./Reagent 1x7,5mL / Adjusters mL (lyophilized) 2x4mL (commercially available) Product Name: IGF-I - IMMULITE (Anvisa Record No. 10345161109) /// Affected Model (s) / Solution 1x30mL /// Affected lot: 411 /// Product risk class: II.

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 Products Ltd...

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
    1896
  • Date
    2016-05-11
  • 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
    AT.
  • Reason
    Siemens healthcare diagnostics has identified that incubation prior to the processing of patient samples takes 24 minutes in the immulite / immulite 1000 system so that the pretreatment solution reaches full equilibrium when using the pre-treatment solution (lgfa) lot 055 , contained in the immulite 2000 igf-i kit, batch 411. if patient samples are processed before full equilibrium is reached, an underestimate recovery of -36% may occur. however, if the sample is incubated for more than 24 minutes before the test, an underestimate will not be observed. there is a potential for a falsely suppressed igf-i value that may delay the diagnosis for acromegaly and / or potential pharmacological treatment to normalize serum igf-i. the impact of clinical potential is mitigated by serum igf-i monitoring as well as by correlation of serum growth hormone dosages and clinical presentation. quality controls will not detect this problem.
  • Action
    Field classification: letter to the client /// Field action code: IMC 16-05 /// Recommendations to users and patients: ensure that the pre-treatment solution is incubated with the patient sample for at least 24 minutes prior to processing in the IMMULITE / IMMULITE 1000 systems.

Device

100 ml Test Kit - Pearls 100u./Reagent 1x7,5mL / Adjusters mL (lyophilized) 2x4mL (commercially a...

Manufacturer

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