Events

Safety Alert for Trade name: Hemoglobin A1C. Technical Name: Hemoglobin. ANVISA registration number: 80146501853. Class of risk: II. Affected Model: Not Applicable. Serial Numbers Affected: 50007UQ10; 50030UQ10; 50279UQ12; 50280UQ12; 50281UQ12; 50282UQ12; 50613UQ02; 50614UQ02; 50615UQ02; 50616UQ02; 50884UQ04; 51177UQ06

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda; Abbott Laboratories.

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
    2466
  • 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
    • Review this statement with your medical director. • Consider the above information when using HbA1c reagents (4P52-21). • Complete and submit the Customer Response Form. • Keep this statement in your lab files. • If you have forwarded any of the products listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/19/2017 - Date of notification notice to Anvisa: 11/01/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    The purpose of this product correction notice is to report that fetal hemoglobin (hbf) interference occurs at a level below that indicated in the instructions for use of hba1c reagents. instructions for use indicate that the hba1c assay is susceptible to hbf interference at> 20%, while the most current data demonstrate hbf interference at> 5%. hba1c results are invalid for patients with abnormal amounts of hbf, including those with known hereditary persistence of fetal hemoglobin. in healthy adults, approximately 95% of hemoglobin is hba, with small amounts (<3.5%) of hba2 and hbf present in f1. although the update of hbf interference impacts all valid lots of reagent inventory 4p52-21 listed above, the update of the specification was not motivated by a process or formula change. further updates will be made in the instructions for use of the hba1c reagents and communicated at the appropriate time.
  • Action
    Field Action Code FA19DEC2017 triggered under the responsibility of the company Abbott Laboratórios do Brasil Ltda. Will make field correction

Device

Trade name: Hemoglobin A1C. Technical Name: Hemoglobin. ANVISA registration number: 80146501853. ...

Manufacturer

Abbott Laboratórios do Brasil Ltda; Abbott Laboratories
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA