Events

Safety Alert for Automatic Range Counter Wizard2, Model 2470 and 2480 Registration 10298910126, I-lot class: SGWZ13130003, SGWZ21330009, SGWZ42130052, SGWZ50130087, SGWZ14140125, SGWZ18140139, DG10129753, DG01130080, DG12120010, DG04130302, SGWZ20140148, SGWZ34140184, and SGWZ42140202.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PerkinElmer do Brasil Ltda.; PerkinElmer Singapore Pte Ltd..

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
    1644
  • Date
    2015-07-22
  • 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
    According to the company the health impact is dependent on the clinical application in which the Gama Wizard² counter is being used. The applications are: gamma count measurement, radioimmunoassay tests, determination of glomerular filtration rates and dose determination of radiopharmaceuticals in nuclear medicine.
  • Reason
    Error in the contents of the second bar code of label no. 23. the label is being incorrectly identified as #. 24 when scanned.
  • Action
    The company that holds the registration guides the immediate destruction of all barcode labels. 23 that are in the possession of the clients. The Wizard2 Gamma Counter contains a total of 20 bar code labels identified as # 23 (ie, 02 labels on each of the 10 pages). Be sure to inspect all sample racks to remove and destroy all # 23 bar code labels already attached to the racks.

Device

Automatic Range Counter Wizard2, Model 2470 and 2480 Registration 10298910126, I-lot class: SGWZ1...

Manufacturer

PerkinElmer do Brasil Ltda.; PerkinElmer Singapore Pte Ltd.