Events

Safety Alert for IMMUNOCARD KITS OF IMMUNOCARD SAMPLES OF IMMUNOCOR SAMPLES LINKED TO ROTAVIRUS ENZYME (IMMUNOCARD ROTAVIRUS ENZYME-LINKED IMMUNOSORBENT ASSAY TEST KITS: PRODUCT NO 708030; LOT NOS .: 708030.139, A .142, .145

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MERIDIAN DIAGNOSTICS INC.

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
    154
  • Date
    2000-07-20
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The negative control dilute / sample of the kits of tests mentioned, indicate false-positive results. the manufacturer started a removal by correspondence, phone and fax on july 20, 2000.
  • Action
    MAKE SURE THAT YOU HAVE BEEN RECEIVED AND RECEIVED THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS DECLARES THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO AFFIRMS THAT KIT DISTRIBUTORS SHOULD DISCONTINUE THEIR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE 1 (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT THE TECHNICAL SUPPORT DEPARTMENT OF YOUR LOCAL MERIDIAN DIAGNOSTICS REPRESENTATIVE

Device

IMMUNOCARD KITS OF IMMUNOCARD SAMPLES OF IMMUNOCOR SAMPLES LINKED TO ROTAVIRUS ENZYME (IMMUNOCARD...

Manufacturer

MERIDIAN DIAGNOSTICS INC
  • Source
    ANVSANVISA