Events

Safety Alert for Trade name: 31 Vitros Calibrator Kit. Registration number ANVISA: 80145901715. Technical Name: Glycated hemoglobin. Risk class: Product classified as II and the control of these systems is performed by lot number. Affected model: 119 calibration kit units have been imported that together with the Assay Data Diskette (ADD) versions 5873, 5874, 5875 and 5876 will not be possible to calibrate

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
    1926
  • Date
    2016-05-19
  • 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, users who own the batch affected by this field action should: • Install the DRV 5877 Assay Data Diskette or later on their VITROS System. After successful calibration and quality control evaluation, it is acceptable to use the VITROS Reagent Kit for HbA1c, GEN 06. NOTE: For electronically connected systems, automatic download was available as of April 12, 2016.
  • Reason
    Impossibility to calibrate the vitros® chemistry products reagent kit for hba1c, generation (gen) 06, when using the vitros calibrator kit, lot 3155 and specific assay data diskettes (5873, 5874, 5875 and 5876). it should be noted that the assay data diskette (add) drv 5877 and later contain the correct calibration data. ortho clinical diagnostics (ortho) has detected an incorrect value (calibration data / mathematics) in the adds listed above for the vitros 31 calibrator kit, lot 3155, used to support the vitros reagent kit for hba1c, gen 06. the value incorrect calibration will prevent successful calibration of the test.
  • Action
    Action required for laboratories that have the affected lot: • Install the Assay Data Diskette DRV 5877 or later on your VITROS System. After successful calibration and quality control evaluation, it is acceptable to use the VITROS Reagent Kit for HbA1c, GEN 06. NOTE: For electronically connected systems, automatic downloading has been available since April 12, 2016. This is a situation where the use of the product is not likely to cause adverse health consequences. Cod. 16000096 - Letter to clients in ANNEX

Device

Trade name: 31 Vitros Calibrator Kit. Registration number ANVISA: 80145901715. Technical Name: Gl...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; ORTHO CLINICAL DIAGNOSTICS, INC