Events

Safety Alert for IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR RUBELLA IgM - registration 80145901047. Lots 0740 and 0751. See Annex 1 - Distribution List

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics.

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
    1466
  • Date
    2014-11-21
  • 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
    The manufacturer informs to assist in the diagnosis of a recent or acute Rubella infection, the IgM test result is usually used in conjunction with patient signs and symptoms as well as a history of potential exposure to Rubella. Independent literature (eg Center for Disease Control Surveillance of Vaccine-Preventable Disease) generally suggests performing a second blood collection 5-10 days later for re-testing of both IgM and IgG Rubeola and / or alternative test method to confirm the infection of Rubeóla to patient with initial IgM positive results. To date, there are no customer complaints reported to the OCD indicating damages to patients who are associated with the affected lots. This event may not be detectable quickly unless the employee observes higher-than-expected results with quality control samples. There may be an increase in the number of patient samples that are on the limit or reactive line compared to the normal distribution of your laboratory and may also indicate that your lot is affected. In addition, there may be an increase in the mean S / C value for negative patient samples at your facility
  • Reason
    The manufacturer has identified potential for false reactive results when using the reagent packs vitros® rubella igm, lots 0740 and 0751 .
  • Action
    The company makes the following recommendations: i) Immediately discontinue use of any remaining inventory units from batches 0740 and / or 0751 of the VITROS® Rubella IgM reagent packs and calibrators. ii) Review previously reported results that have a signal / cutoff value of 1.20 - 1.90 generated by using the VITROS ® Rubella IgM reagent packs, Lots 0740 and / or 0751. iii) Discuss any concerns regarding previously reported results with your Medical Laboratory Director or request that a physician determine the most appropriate ongoing course of action. iv) Refer this information to others involved if you have distributed this product outside your facility. For more information, please check the Letter to the Client - Annex II

Device

IMMUNODIAGNOSTIC REAGENT KIT VITROS * FOR RUBELLA IgM - registration 80145901047. Lots 0740 and 0...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics