Events

Safety Alert for IMMUNOSORBENT ASSAY TEST KITS (IMMUNOSORBENT ASSAY TEST KITS) IMMUNOSORBENT SAMPLES TEST KITS: PRIMARY RUBEOLA IMMUNOGLOBULIN G ENZYME-LINKED IMMUNOSORBENT ASSAY TEST KITS: PRODUCT NO. RBE100; LOT NO. RBE100.002

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
    149
  • Date
    2001-10-13
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The reference control of the test kits mentioned does not meet the specifications, which could lead to false-negative results. the manufacturer started a removal by correspondence dated july 21, 2001.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF JULY 21, 2001 AND THE MERIDIAN DIAGNOSTICS KNOWLEDGE FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. MERIDIAN DIAGNOSTICS AFFIRMS THAT CONSUMERS SHOULD DISCONTINUE THE USE OF THESE KITS AND DISCARD THEM. MERIDIAN DIAGNOSTICS ALSO SAYS THAT KIT DISTRIBUTORS MUST DISCONTINUE YOUR DISTRIBUTION, NOTIFY REMOVAL CONSUMERS, AND PROVIDE A COPY OF THE KNOWLEDGE FORM. FILL IN THE KNOWLEDGE FORM AND FAX FOR MERIDIAN DIAGNOSTICS ON PHONE (513) 272-5432. MERIDIAN DIAGNOSTICS WILL REPLACE ANY PRODUCT AFFECTED BY A REPLACEMENT KIT, WITHOUT ADDITIONAL COSTS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR MERIDIAN DIAGNOSTICS REPRESENTATIVE.

Device

IMMUNOSORBENT ASSAY TEST KITS (IMMUNOSORBENT ASSAY TEST KITS) IMMUNOSORBENT SAMPLES TEST KITS: PR...

Manufacturer

MERIDIAN DIAGNOSTICS INC
  • Source
    ANVSANVISA