Events

Safety Alert for Product name: Tina-quant HbA1c Gen.2 Technical name: HEMOGLOBIN GLICED Registration number ANVISA: Hazard class: II Model affected: Serial numbers affected: Lots distributed in Brazil for Product 4528123190: 11642201; 12661801; 6,017,2801; 60450301; 60801901; 6,089,850; 61710701; 68050801; 69089201; 69127401; 69337401; 69655201; 69986701; 69989301. Lots distributed in Brazil for Product 5401640190: 11641901; 60224601; 60802301; 61061101; 61711001; 69128101; 69337901; 69655601.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

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
    2154
  • Date
    2016-10-21
  • 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
    Recommendations to the customer / user: - Ensure that adequate storage conditions are maintained as indicated in the instructions for use: 2 - 8 ° C. - Based on this issue, which is occurring sporadically, customers who use the Tina reagent -what HbA1c Gen.2 are now directed to perform QC measurements on each respective bottle of reagent packaging in order to detect potentially affected products. - If the QC can not be kept within the specified range, the cassette of the respective vial should not be used for measurements. - The use of Tina-quant HbA1c Gen.3 reagent in cobas c systems is with appropriate solutions as it is unaffected by this issue. For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    With this notification, roche diagnostica informs its customers about a possible increase in quality control (qc) recovery and patient samples in single packs of several lots of the tb-quant hba1c gen. 2 reagent when frozen. due to this issue, an update on the instruction instruction will be required for qc measurements on each respective reagent package vial to be performed in order to detect potentially affected products.
  • Action
    Field Action Code SBN-CPS-2016-019 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Product name: Tina-quant HbA1c Gen.2 Technical name: HEMOGLOBIN GLICED Registration number ANVISA...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH