Events

Safety Alert for Product: Gold ELISA Chagas - Registration: 10162410454 - Technical Name: TRYPANOSOMA CRUZI - Risk Class: III (Products presenting high risk to user, patient and / or public health) - Affected lots: CHA127A; CHA 128A (Distribution map in ANNEX).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by REM Indústria e Comércio Ltda.

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
    1581
  • Date
    2015-05-25
  • 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
    According to the company, "at the end of the test, the reader (equipment used in the IVD trials) releases results values ​​that must meet the acceptance criteria indicated in the Instructions for Use. The results are analyzed by qualified persons. is foreseen in the Risk Management Report of the Gold ELISA Chagas kit, considered as a serious risk since failure to meet these criteria invalidates the reaction and makes it impossible to release results. "
  • Reason
    The company received a complaint about the performance of the positive control part of the gold elisa chagas kit, lot cha127a. it carried out investigation and concluded that this reagent presents problems with the stability being able to be outside the required minimum specifications and not to reach the result of expected optical density for the release of the test. in the traceability analysis of the production process, it was identified that the positive control pertaining to the kit cha128a lot has common components with that used in lot cha127a and, as a precaution, included it in the field action. according to the company, the investigation of the occurrence provided subsidies so that they could make sure that the problem is restricted to the positive control.
  • Action
    Company is performing the recall (for destruction of affected lots) and directing its customers to discontinue use of lots CHA127A and CHA128A. (SEE ANNEXES) - Code: NP 80/15

Device

Product: Gold ELISA Chagas - Registration: 10162410454 - Technical Name: TRYPANOSOMA CRUZI - Risk...

Manufacturer

REM Indústria e Comércio Ltda