Events

Safety Alert for Diluente / Sheath - Record nº 10055310747

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil Ltda - Divisão Diagnósticos.

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
    795
  • Date
    2004-12-15
  • 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
    No medical damage or events have been reported on the CELL DYN 3200 equipment when using Diluent / Sheath CD 3200 lot number 10055310747 between February 24, 2004 and September 10, 2004. Always make sure that the background counts are in of the specifications before testing controls and patient samples. If the control results are within acceptable limits, but background counts are out of specification, DO NOT TEST SAMPLES OF PATIENTS. If contaminated reagents are suspected, this may have contaminated the Diluent / Sheath filter. Consequently, the filter must be changed before using the reagent batch. Filter torch instructions are found in the Monthly Maintenance Section of Chapter 9: Services and Maintenance. If the Diluent / Sheat CD 3200 with lot number 1795412 is in stock, discontinue using the lot listed if the platelet count is above 0.5 / ul as mentioned in the CD 3200 Operating Manual. Continued use of the said lot if the platelet count is up to 0.5K / ul. Fill in the Response Protocol for later return of the product. Abbott Laboratories will collect the material and provide a refund. Contact your Abbott representative to request a replacement. For any additional questions or concerns, contact the Abbott Customer Service Center Diagnostics Division Telephone 0800-11-9099.
  • Reason
    Some bottles of diluent / sheth cd 3200, lot 1795412, showed a higher than expected platelet count when used in the cell-dyn 3200 device. tests have identified a contaminant trace in the reagent that appears to be the cause of or a factor contribution to high platelet counts. analytical tests indicate that the contaminant is a high boiling oil, which may form an emulsion in the reagent as a result of agitation and aging. it is believed that the emulsion is raising platelet background counts.
  • Action
    The source of such contaminants and / or any composition factors is under investigation. The initial action consisted of an increase in recently-sampled lots of Diluent / Sheath CD 3200 made for platelet background counts. Additional actions will be determined on the basis of the results of the research

Device

Diluente / Sheath - Record nº 10055310747

Manufacturer

Abbott Laboratórios do Brasil Ltda - Divisão Diagnósticos
  • Source
    ANVSANVISA