Events

Safety Alert for LIFECODES HLA-C eRES SSO

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by IMMUCOR TRANSPLANT DIAGNOSTICS, INC || Importer: BIOSCIENCES S.A.S.

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
    IRD-010616
  • Event Number
    INVIMA 2014RD-0002729
  • Date
    2016-06-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The threshold set for probes 380, 382, 384 and 385 are high insertion and may result in false negative results. probe 380 resolves allele c * 03: 06, probe 382 resolves allele c * 12: 3, probe 384 solves allele c * 01:08 and probe 385 solves allele c * 08: 06. the risk for the patient is considered low, due to the low frequency of the alleles that are detected by these probes. due to the complex nature of hla, qualified personnel should review the interpretation of the data and results of the labeling, in accordance with the limitations of the procedure in the insert of the product.

Device

LIFECODES HLA-C eRES SSO

Manufacturer

IMMUCOR TRANSPLANT DIAGNOSTICS, INC || Importer: BIOSCIENCES S.A.S
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    NIDFSINVIMA