Events

Safety Alert for VITROS IMMUNODIAGNOSIS CALIBRATOR FOR CA 125 II, Registration nº 10132590524, lots: 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.

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
    1314
  • Date
    2013-10-18
  • 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 company informs that the tests have confirmed that Batches 1240 and 1250 continued to perform within the product specifications and that it is acceptable to continue using the remaining inventory by the expiration date as long as the quality control results are within acceptable limits . Note: Lot 1240 expires on October 16, 2013; Lot 1250 expires on November 15, 2013.
  • Reason
    The company holding the record reports an investigation has detected that the signal for all affected batches levels of the vitros ca 125 ii ™ calibrators increased during the shelf life of the product, resulting in negative bias in patient outcomes and control of quality. the internal tests confirmed that this is an isolated problem for lots 1220, 1230, 1240 and 1250. the observed maximum bias was -15%, since lot 1240 was near the expiration of its expiration date compared to lot 1270. as a result of negative bias and normal batch-to-batch variation, a significantly positive deviation in patient outcomes and quality control can be observed when using lot 1260 or above when compared to affected batches.
  • Action
    The company advises clients to consider the need to review the results of patients for whom they have used affected batches. If you suspect that the previously reported result may have been affected, please provide this information to your Laboratory Medical Director and the requesting physician or health professional so that appropriate actions can be taken for patients with ovarian epithelial cancer whose response to therapy is being monitored with the VITROS CA 125 II ™ test. Report the occurrence to our Technical Services representatives to the Customer. - Complete and return the attached Confirmation of Receipt form. - Forward the information in this notification if you have distributed this product outside your facility. See letter to the Client (Annex III).

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR FOR CA 125 II, Registration nº 10132590524, lots: See Annex 1 -...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda