Events

Safety Alert for CELL - DYN 26 CONTROL. Nº LIST 1H71-01 - Lot No: CD013

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.

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
    714
  • Date
    2003-02-28
  • 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
    - Use the revised protocol (No. 9155136E) for product CELL DYN Control 26, lot CD013 and enter the correct value for HCT (all levels), MCH (low level) and MCHC (low level) in the System Quality Control file CELL-DYN 3200 following the instructions in the CELL DYN 3200 Operator's Manual, section 5. - Disregard the protocol prior to no. 9155136E of the CELL DYN product Control 26 above for lot CD013 - If you have established your own measures and ranges for lot CD013 , and inserted them into the Quality Control files of the Cell Dyn 3200 instrument, disregard the protocol of the CELL DYN Control 26 product. For more information, contact the Customer Service Center at 0800-119099.
  • Reason
    The abbott laboratories - diagnostics division reports a review of the parameters of hct (all 3 levels), mch (low level only) and mchc (low level only) for the cell-dyn control 26, lot cd013, only for the cell- dyn 3200.
  • Action
    The Abbott Laboratories - Diagnostics Division, revised the values ​​of the CELL-DYN Control 26 protocol, lot CD013, for the CELL-DYN 3200 System only and updated the values ​​for the HCT (all 3 levels), MCH low) and MCHC (low level only).

Device

CELL - DYN 26 CONTROL. Nº LIST 1H71-01 - Lot No: CD013

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA