Events

Safety Alert for Lifecodes LSA Class II

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by INMUCOR TRASPLANTS DIAGNOSTICS, INC || Imported by: SERVICIOS MEDICOS YUNIS TURBAY || Y CIA. 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-070916
  • Date
    2016-09-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 health agency notifies, that immucor reported that 16 delos 200 kits packed on 22 / july / 2016 of lot 06166k, were affected, in the sense, that these kits contain the positive control lsa1 (265 101), lot 06076d, instead of containing the positive control lsa2 (265 201) of lot 06026a, which is the one corresponding to the product. therefore, when using control lsa1 (265 101) of batch 06076d, the ranges of reactivity will not coincide with those described in the product insert.

Device

Lifecodes LSA Class II

Manufacturer

INMUCOR TRASPLANTS DIAGNOSTICS, INC || Imported by: SERVICIOS MEDICOS YUNIS TURBAY || Y CIA. ...
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Source
    NIDFSINVIMA