Events

Safety Alert for Name of products: Calibrator Kit 29 Vitros *. Technical Name: Total Iron Connection Capacity (TIBC). Registration number: 80145900910. Product code 6802344. Lots affected and imported into Brazil: 2915; 2995. 89 reagent kit units were imported

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
    1956
  • Date
    2016-07-12
  • 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
    This is a situation in which the use of the product is not likely to cause adverse health consequences. Action Required for Laboratories that Own the Affected Lot: • As soon as available, install ADD DRV 5884 or later on your VITROS system. • E-Connected Systems: Automatic download will be available in early May 2016. • ADD DRV 5884 or later will also be shipped to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Fill out and return the Receipt Confirmation form If you have any questions regarding this field action, please contact Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. by telephone: 12 3932-7977 or e-mail: gbuosi@its.jnj.com
  • Reason
    The manufacturer has detected that there are incorrect values ​​(data / calibration math) on assay data diskettes (add) for calibrator kit 29, which supports the vitros dtibc, gen 30 reagent. incorrect values ​​will cause a positive trend in the sample results (ie, patient samples, proficiency fluids, and quality control fluids).
  • Action
    Field Action No. 16000095 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Action Required for Laboratories that Own the Affected Lot: • As soon as available, install ADD DRV 5884 or later on your VITROS system. • E-Connected Systems: Automatic download will be available in early May 2016. • ADD DRV 5884 or later will also be shipped to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Complete and return the Receipt Confirmation form

Device

Name of products: Calibrator Kit 29 Vitros *. Technical Name: Total Iron Connection Capacity (TIB...

Manufacturer

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