Events

Safety Alert for Trade name: Vidas LH. Technical Name: LH Luteinizing Hormone. ANVISA registration number: 10158120127. Risk class: II. Model Affected: Not applicable. Serial Number Affected: Lot: 1005940920

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomérieux brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A..

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
    2518
  • Date
    2018-03-13
  • 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
    1- Destroying the units in stock from lot 1005940920. In Brazil, to try to ensure that no customer will use the units of the product, we decided to collect the 02 units distributed to the market. 2- Inform all staff about the occurrence communicated by our company through the letter to the clients. 3. That it be discussed with its technical staff, the question regarding the results previously released with lot 1005940920. The results should be reviewed and interpreted considering the clinical context. 4- Fill in the knowledge form that accompanies the letter to the clients and return to the 0800 of Biomérieux Brazil. 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: 01/03/2018 - Date of notification notice for Anvisa: 09/03/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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
    Customer complaints were registered due to "invalid calibration" when using the product batch vidas lh lot: 1005940920. this is the only lot among those where the problem was identified, which was imported into brazil. tests performed by the manufacturer reduced the s1 signal to lot 1005940920. cross-tests between the strips and the solid phase receptacle (spr) allowed the conclusion that the decay of the signal was related to the strips. the defieto was raised for the manufacturer due to complaints received from customers, but were related to all tests done (calibration and testing with patient samples). by testing control 1 (c1) and extra samples during the validation of the calibration test, out-of-specification results were demonstrated for some samples. this allowed us to conclude that it may have had an impact on those reusltados with patient samples. in addition to the decrease in the signal from the strips, tests with reactants from different sources (retention kits / kits returned from clients / kits stored in the manufacturer's quality control) showed heterogeneity with lot 1005940920 for the strips signal or the calibration is (with s1 low), or calibration is valid (with s1 valid, sometimes near the lower limit). on the market two situations can occur when using vidas lh lot 1005940920: 1- invalid calibration occurs: in this case an error message will appear on the instrument and the customer will not be able to perform additional tests with the batch in question. there will be no risk of issuing false result to the patient. in this context the risk / impact for the patient is the delay in the emission of the results due to invalid calibration. 2- a valid calibration may occur.
  • Action
    Field Action Code FSCA 3816 triggered under the responsibility of the company Biomérieux brasil Indústria e Comércio de Produtos Laboratoriais Ltda. It will make recollection.

Device

Trade name: Vidas LH. Technical Name: LH Luteinizing Hormone. ANVISA registration number: 1015812...

Manufacturer

Biomérieux brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A.