Events

Safety Alert for Trade name: CELL-DYN RUBY Technical name: HEMATOLOGICAL ANALYZER ANVISA registration number: 80146501507 Hazard class: II Affected model: Not applicable

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

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
    2229
  • Date
    2017-03-17
  • 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
    1. Your Abbott service team will contact you to replace the PCBA Pump Relay Plate on the impacted equipment (s) at no cost. 2. Make sure you have a back-up device or alternate method to generate hematology results if the equipment becomes inoperative. 3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice. 4. Keep this statement in your lab files.
  • Reason
    Abbott hematology has learned that the cell-dyn ruby equipment in its laboratory has a printed circuit board (pcba) assembly that may fail prematurely and result in loss of vacuum / pressure. the pcba pump relay board failure will result in system started messages (sims), including but not limited to the following, and will no longer function: 0840 vacuum accumulator # 1 wet, 1093 mix head failed to complete downward rotation, 1095 mix head not top position, 1096 mix head stuck at top position, 0643 wbc lyse empty * [empty wbc lysis reagent *], 0645 dil / sheath empty *. for messages 0643 and 0645, make sure that the reagent is not empty. if the error message is related to this problem, the machine will stop and you will need to replace the pcba to continue.
  • Action
    Field Action Code FA13FEB2017 Revision 01 released under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

Trade name: CELL-DYN RUBY Technical name: HEMATOLOGICAL ANALYZER ANVISA registration number: 8014...

Manufacturer

Abbott Laboratórios do Brasil; ABBOTT LABORATORIES
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA