Events

Safety Alert for MICROPLATES ACCOMPANYING THE PRODUCTS: NEONATAL TOTAL GALACTOSE - Record 10298910089 - NEOGRAPHY AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTOMETRY - Record 10298910091 and NEOBASE NON-DERIVATIZED MSMS - Registration 10298910097 - AFFECTED LOTS - 1061734101, 1061923601, 1061734501, 1061856301, 1061856601, 1061955301, 1061820101 , 1061820103, 1061890801, 1062000801, 1061969601, 1061876501, 1061945401, 1061947301, 1061920002, 1062020001, 1061826301, 617792, 618609, 620062.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PerkinElmer 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
    1208
  • Date
    2012-12-03
  • 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
    After a microscopic inspection of 25,000 microplates, the defective wells were identified as present only on line A or line H of the microplate; most commonly observed in the wells located at the corners of plates A1, A12, H1 and H12. Anvisa follows this Field Action.
  • Reason
    Microplates packed with batch numbers of products listed above may include microplates with defective wells. the defect is a hole or crack at the bottom of the well.
  • Action
    Visually inspect the wells of lines A and H, visual monitoring to confirm that before and after incubation the volume of the solution is not reduced, resulting in replacement of the microplates. See attached Letter to the Client. http://en.wikipedia.org/w/index.php?/

Device

MICROPLATES ACCOMPANYING THE PRODUCTS: NEONATAL TOTAL GALACTOSE - Record 10298910089 - NEOGRAPHY ...

Manufacturer

PerkinElmer do Brasil Ltda.