Events

Safety Alert for CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner Registration Number ANVISA: 80146501650 ### Hazard Class: I (PRODUCTS OF LOW RISK TO INDIVIDUAL AND LOW RISK TO PUBLIC HEALTH, SUBJECT TO REGISTRATION) ### Lot : 7044

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 Diagnostics Division..

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
    1974
  • Date
    2016-08-25
  • 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
    Recommendations to Users and Patients: If you HAVE an alternative lot of Emerald Cleaner available in stock (except 6853, 6901, 6953, 6991, 7024 or 7027), immediately discontinue use of impacted lots of Emerald Cleaner. 1. Start using the alternative lot of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1 -3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Return the remaining stock of the impacted batches of Emerald Cleaner according to your laboratory procedures. If you do not have an alternative batch available and you are not observing QC outside the low range for RBC and PLT parameters, immediately request a replacement lot from Emerald Cleaner. Make sure you meet your internal QC requirements. You can continue to use the batch until the replenishment arrives. After you receive the replacement batch, follow steps 1-3: 1. Begin using the alternative batch of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1-3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Please return the remaining stock from lots 7044, 7082, 7110 or 7119 according to your laboratory procedures. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Abbott has previously identified occurrences where the cell-dyn emerald analyzer generated out-of-range qc results for the rbc and plt parameters when using emerald cleaner lots 6853, 6901, 6953, 6991, 7024, and 7027 tests with lots 7044, 7082, 7110, and 7119 confirmed the out-of-range rbc and plt controls. the cause of the problem (qc material outside the low range) has been identified in the manufacturing process of a raw material used in the cell-dyn emerald cleaner.
  • Action
    Field Action FA24MAR2016 - Revision 02 triggered under the responsibility of Abbott Laboratories of Brazil. Gathering for Destruction

Device

CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner Registration Number ANVISA: 80146501650 ### H...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Laboratories Diagnostics Division.
  • 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