Events

Safety Alert for Name of Elecsys TSH and Elecsys PTH (1-84) Technical Name: THYROID STIMULATING HORMONE (TSH) and INTACT CATHOLIC HORMONE (iPTH) ANVISA Registration Number: Hazard Class: II Model Affected: Serial Numbers Affected: 185522

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
    2216
  • Date
    2017-03-02
  • 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
    Actions taken by Roche Diagnostica: Preventively, Roche Diagnostica Brasil interrupted the distribution of lot 185522 of the Elecsys TSH assay for customers using the cobas and 602 module and who in the past purchased lot 185522 from the Elecsys PTH assay (1-84). Roche Diagnostics GmbH, manufacturer of the product, has taken all necessary measures with immediate effect to ensure that any batch number of the product is unique. Actions to be taken by the customer / user Do not use Elecsys TSH assay lot 185522 in any configuration of the cobas 8000 modular analyzer series (which includes the cobas and 602 module) in which lot 185522 of the Elecsys PTH assay (1-84) was previously used. Please change to batches 189279 and 212491 of the Elecsys TSH assay available. If you have not previously used lot 185522 of the Elecsys PTH assay (1-84) in the cobas 8000 modular analyzer series (which includes the cobas and 602 module), you can use lot 185522 of the Elecsys TSH 185522 assay without any restrictions. If you are affected by this problem: If hyperthyroidism is excluded only by measurement of TSH, repeat the test for results between 0.26-0.36 μIU / mL if clinical symptoms point to hyperthyroidism. For further questions and support, please do not hesitate to call our CEAC Service Center - 08007720295 or your Roche Diagnostica Brasil Ltda representative. #### 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
    Roche diagnostics gmbh, the manufacturer of the product involved in this notification, informs its customers that the concomitant use of the pth test (1-84) lot 185522 and the tsh test lot 185522 in the cobas and 602 module may generate inappropriate information for the tsh test. it is worth mentioning that, in preventive terms, roche diagnóstica brasil interrupted the distribution of lot 185522 of the elecsys tsh assay for customers using the cobas and 602 module and who had previously purchased lot 185522 of the elecsys pth assay (1-84).
  • Action
    Field Action Code SBN-CPS-2017-001 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will letter to customers.

Device

Name of Elecsys TSH and Elecsys PTH (1-84) Technical Name: THYROID STIMULATING HORMONE (TSH) and ...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH