Events

Safety Alert for CELL DYN 4000 WBC Reagent Part AN ° List: 01 H77-01 Lot No: 18087-12 or higher.

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
    788
  • Date
    2004-08-13
  • 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
    Any questions regarding the information contained in this release, please call the Customer Service Center, Tel 0800-11-9099- Abbott Diagnostics Division. This Product Information has been developed by the Abbott Diagnostics Division to inform you of the change in the CELL DYN® 4000 WBC Reagent Part ANA list: 01H77-01.
  • Reason
    The abbott diagnostics division has adopted a new supplier of saponin, used in the cell dyn® 4000 wbc reagent part a. tests have indicated that the new formulation, with the new supplier of saponin (used to lyse the red blood cells), can generate a slight increase in flag rrbc (resistant red blood cell). a total of 119 samples, including 68 abnormal samples, were tested with the following results: · 2 samples with rrbc flag, with the current formulation (lower than batch no. 18087-12) · 5 samples with rrbc flag, with new formulation ( above the lot # 18087-12). you may notice a slight increase in the rrbc (resistant red blood cell) flag for lot # 18087-12 or higher.
  • Action
    File this release in the CELL DYN® 4000 Operator's Manual, and fill out the Response Protocol and send via fax Fax: 0XX 11 - 5536 7181

Device

CELL DYN 4000 WBC Reagent Part AN ° List: 01 H77-01 Lot No: 18087-12 or higher.

Manufacturer

Abbott Laboratórios do Brasil Ltda
  • Source
    ANVSANVISA