Events

Safety Alert for CALIBRATION MODULE (CDM PROM) VITROS® NH3 DT Slides, GEN 59 - Code 1532589 - Registration 80145900916 - 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; 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
    1672
  • Date
    2015-08-27
  • 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 reinforces the inability to calibrate or use the VITROS® NH3 DT Slides, GEN 59 with the VITROS® DT Calibrator Kit, Lot 44, when the CDM PROM 0168 or 0169 is installed. During use, the operator will be required to operate bottles 1, 2, 4, and 4 instead of bottles 1, 2, 3, and 4. The customer will not be able to enter the information necessary to calibrate the assay.
  • Reason
    The registrant informs that product corrective action has been initiated due to the inability to calibrate or use vitros® nh3 dt slides, gen 59 with vitros® chemistry products dt calibrator kit, lot 44, when cdm prom 0168 or 0169 is installed on the vitros® dt60 / dt60 ii systems.
  • Action
    • If you have the VITROS® DT Calibrator Kit, Lot 42, you can calibrate your current inventory of VITROS® NH3 DT Slides, GEN • If you have the VITROS® DT Calibrator Kit, Lot 42, you can calibrate your current inventory of VITROS® NH3 DT Slides, GEN 59 with CDM PROMs 0168 or 0169. • If the installation uses the VITROS® NH3 DT Slides and you need the CDM PROM 0170 to calibrate, enter in the Receipt Confirmation form the number of CDM PROMs that your installation needs. Further information - Annex 2 - Customer communication

Device

CALIBRATION MODULE (CDM PROM) VITROS® NH3 DT Slides, GEN 59 - Code 1532589 - Registration 8014590...

Manufacturer

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