Safety Alert for Trade name: Elecsys Vitamin D total II. Technical name: Vitamin D. ANVISA registration number: 10287411273. Class of risk: II. Model Affected: N / A. Elecsys Vitamin D total II (100 tests) (Code: 7464215190 and Record: 10287411273) lots under risk in Brazil: 27398201/29822801 / 27398202. Elecsys Vitamin D total II (300 tests) (Code: 7028148190 and Registry: 10287411242) lots under risk in Brazil: 23010601/27396201

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Perform the following actions prior to Elecsys Vitamin D total II measurements on all analyzers. These actions represent a step-by-step approach to improve the quality of the sample prior to measurement with the Elecsys Vitamin D total II assay and should be performed temporarily, until additional information is provided by the company: 1. Perform a thorough inspection of your pre-treatment for the correct performance of the Elecsys Vitamin D total II assay and to meet the individual specifications of the primary tube manufacturers for all tubes in use (in particular, centrifuge conditions are important and foam / bubble elimination). 2. If the problem persists in plasma samples, switch to serum. 3. If you still find the problem in plasma or serum, centrifuge again in a secondary tube for 10 min in 2000 xg before measurement with Elecsys Vitamin D total II. (use secondary tubes within accepted specifications, see operator's manual). If suggestions 1, 2 and 3 do not improve the problem, consider switching to Total Elecsys Vitamin D (code 05894913190) and contact your Roche Diagnostics Representative in 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: 04/13/2018 - Date of notification notice to Anvisa: 04/27/2018 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
    Occurrence of performance problems during the implementation of the elecsys vitamin d total ii assay in modular analytics e 170, cobas and 601 and cobas and 602 systems, which may result in falsely elevated results. the company has developed temporary measures that should be considered prior to the use of the elecsys vitamin d total ii product on all analyzers.
  • Action
    Field Action Code SBN-CPS-2018-005 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Notice on temporary measures to be considered before use of the product.