Events

Safety Alert for VANG VITROS REAGENT KIT Technical Name: VANCOMICINE ANVISA Registration Number: 80145900812 Hazard Class: II Affected Model: Box with 6 kits (Reagent 1: 9.7ml / Reagent 2: 4.9ml) Lot / Serial Numbers affected: SKU 6801709, lot 315506

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, Inc..

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
    2261
  • Date
    2017-04-11
  • 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
    • Immediately discontinue use and dispose of all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. NOTE: If you do not have an alternate lot in your inventory, refer to the information provided on page three for instructions on using your current lot until the replacement products arrive. • Complete and return the Receipt Confirmation. • Place this notification next to each VITROS System that uses the VITROS VANC Reagent Packs products or together with your user documentation
  • Reason
    Ortho clinical diagnostics (ortho) has identified the potential for deviated results generated by using the vitros vanc reagent product for the lots indicated above. this may occur after loading the reagent kits into the analyzer and storing them for the duration of stability in the analyzer. some clients observed a positive standard deviation (sd) of> 2 in the quality control results when using vitros tdm performance verifiers (levels i, ii and iii).
  • Action
    Field Action Code TC2017-041 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

VANG VITROS REAGENT KIT Technical Name: VANCOMICINE ANVISA Registration Number: 80145900812 Hazar...

Manufacturer

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