Events

Safety Alert for Abbott CELL-DYN Analyzers: (1) Model 3200 CS, (2) Model 3200 SL, list of numbers: (1) 04H59-01, 04H59-03; (2) 04H60-01, 04H60-03; serial number: (1) 29983AH to 29993AH, (2) 60873AF to 60906AF; units manufactured after June 23, 2000 that contains 486 microprocessor chips

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratories Diagnostic Div.

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
    333
  • Date
    2001-11-16
  • 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
    ANVISA is interested in following if there has been good collaboration of the manufacturer | your laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.
  • Reason
    At elevated temperatures, the above analyzers may exhibit a variation in haematological results due to a failure of the 486 microprocessor chip. the manufacturer initiated the removal by telephone on august 30, 2000 and by letter dated september 7, 2000.
  • Action
    Check your phone receipt on August 30, 2000 and / or the letter dated September 7, 2000 from Abbott Laboratories. Discontinue use of the above product and use another method to report haematological results until an Abbott representative can visit your facility. If your Model 3200 CS or Model 3200 SL CELL-DYN analyzer has been installed, a local Abbott representative must have checked your drive and replaced the defective 486 microprocessor chip with a good 486 microprocessor chip. If you are a new customer of CELL-DYN and your analyzer has not been installed, your local Abbott representative will inspect and replace any defective 486 microprocessor chips during installation in your unit. For more information, please contact your local representative.

Device

Abbott CELL-DYN Analyzers: (1) Model 3200 CS, (2) Model 3200 SL, list of numbers: (1) 04H59-01, 0...

Manufacturer

Abbott Laboratories Diagnostic Div
  • Source
    ANVSANVISA