Events

Safety Alert for REAGENT FOR SEROLOGY, ANTI-TP ELISA KIT

According to Digemid, this safety alert involved a device in Peru that was produced by BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO. 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
    ALERTA DIGEMID Nº 49 - 2015
  • Date
    2015-09-11
  • Event Country
    Peru
  • Event Source
    Digemid
  • Event Source URL
    http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2015/ALERTA_49-15.pdf
  • Notes / Alerts
    Peruvian data is current through August 2018. All of the data comes from Digemid, 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 recall data from the U.S. and Peru.
  • Extra notes in the data
  • Reason
    Non conforming to the sensitivity test.

Device

REAGENT FOR SEROLOGY, ANTI-TP ELISA KIT

Manufacturer

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO. LTD.
  • Manufacturer Parent Company (2017)
    Yangshengtang Co. Ltd.
  • Manufacturers representative
    DROGUERIA COMERCIAL IMPORTADORA SUDAMERICANA S.A.C.
  • Source
    Digemid