Events

Safety Alert for Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2mL) - Registration 10345161815. - Batches GA4266; BA4273; BA4280; BA4287; GA4301; GA4315; GC4322; GA4343; GA4350; GA4357; GA5013; GA5020

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda..

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
    1446
  • Date
    2014-10-21
  • 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
    The monitoring of patients with hyperglycemia depends on diet, lifestyle, glucose concentrations, HBA1c and adjustments of therapies for glycemic control. A positive bias of up to 1.0% [11 mmol / mol] for HbA1c may be considered clinically significant at relevant values ​​and may result in modification of therapy for hyperglycemia. Modification of hyperglycemia therapy may increase the risk of hypoglycaemia, which can be observed by monitoring the patient's blood glucose and / or symptoms.
  • Reason
    Siemens has confirmed that the dimension® hb1c flex® kit for lots ga4266; ba4273; ba4280; ba4287; ga4301; ga4315; gc4322; ga4343; ga4350; ga4357; ga5013 and ga5020 present a mean positive bias of 0.4% [4.4 mmol / mol] in hemoglobin a1c and occasionally 1.0% [11 mmol / mol] in hba1c for patients compared to the national glycohemoglobin standardization program (ngsp). controls can display the same performance. depending on the quality control limits, this problem may not have been detected.
  • Action
    The company advises customers to discontinue use of the product, segregate any remaining stock from the affected lot of the HB1C Dimension Glycosylated Hemoglobin Flex Reagent in order to return these products to Siemens and to keep the letter with the laboratory records.

Device

Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA