Events

Safety Alert for Trade name: Family of Differentials for Ident. by Microorg. - VITEK 2 - Identification (GP TEST KIT VTK2). Technical name: M. de Cultura e Dispos. Differ. Intended for Identif. by Microorg. by means of Biochemical Tests. ANVISA registration number: 10158120571. Risk class: II. Affected model: Not applicable. Serial numbers affected: 2420348103, 2420198203, 2420198203, 2420200103, 2420204103, 2420205103, 2420220403, 2420214403, 2420217203, 2420220203, 2420226403, 2420229203, 2420239203, 2420243203, 2420247203, 2420248403, 2420248203 ,. 2420253203, 2420261403, 2420267103, 2420282403, 2420289403, 2420290103, 2420296403, 2420300203, 2420302103, 2420303103, 2420307103, 2420309403, 2420314203, 2420317203, 2420317403, 2420320103, 2420321103, 2420322103, 2420330113, 2420331403, 2420352403, 2420353403

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by bioMperieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomérieux 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
    2427
  • Date
    2017-10-18
  • 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
    Identify VITEK® 2 customers regarding the receipt of any batch (s) of the Vitek 2 GP ID card, referenced in FSCA 3666 and send to them the Urgent Product Correction Notice to ensure awareness of the identified problem and instruct in relation to the actions defined. 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: 09/22/2017 - Date of notification notice to Anvisa: 10/18/2017 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 health risk assessment was performed by physicians and it was determined that the clinical impact was remote to the populations of patients at risk and unlikely for populations of normal patients. growth pattern analysis identified that only 5 microorganisms represent a risk of a positive atypical dsor reaction and, therefore, a misidentification of the microorganism. for 4 of 5 microorganisms unlikely that potentially misidentification would have a significant negative impact on patients. wrong identification of (1) microorganism that could potentially have a negative impact on the patient, streptococcus gallolyticus (gallolyticus subsp.), is a very unusual cause of infection. each of these 5 microorganisms could be sent to ast (antibiotic susceptibility test) and interpreted using breakpoints available for the respective group: 1) streptococcus spp. viridans group, 2) enterococcus spp., and 3) staphylococcus spp. therefore, an incorrect identification should not have any negative impact on the interpretation of ast (antibiotic susceptibility test) results. based on the health risk assessment, this problem represents a lower overall risk.
  • Action
    Field Action Code FSCA 3666 triggered under the responsibility of the company bioMperieux Brazil Ind and Com de Prod Laboratoriais Ltda. Orientation of the clients regarding the actions defined.

Device

Trade name: Family of Differentials for Ident. by Microorg. - VITEK 2 - Identification (GP TEST K...

Manufacturer

bioMperieux Brasil Ind e Com de Prod Laboratoriais Ltda; Biomérieux Inc