Events

Safety Alert for Xpert® HIV-1 Viral I II

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by CEPHEID AB || Imported by:ROCHEM BIOCARE COLOMBIA || 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
    RRD-030916
  • Event Number
    INVIMA 2015RD-0003345.
  • Date
    2016-09-27
  • 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 sanitary agency notifies, that the cepheid manufacturer has received reports that some of the clients have had problems of performance of the cartridges, where the curve of the amplification pattern of the pcr, is abnormal, which can generate invalid results, incorrect quantification of arnvih-1, use this test. therefore, cephied will provide product replacement gxhiv-vl-ce-10 lot 1000034821 (cartridge lot 14001) or gxhiv-vl-ce-10 lot 1000036280 (cartridge lot 14002) to customers who have inventory referenced lots. it is not recommended to give a final disposition of the product, which is found in inventory.

Device

Xpert® HIV-1 Viral I II
  • Model / Serial
    CATALOG: GXHIV-VL-CE-10 || LOT: 1000034821 (CARTRIDGE LOT 14001) || GXHIV-VL-CE-10 LOT. 1000036280 (CARTRIDGE LOT 14002).
  • Product Description
    DIAGNOSTIC TEST DESIGNED FOR THE QUICK QUANTIFICATION OF HUMAN HIV-1 TYPE VIRUS (HIV-1) IN PLASMAHUMAN FROM PERSONS INFECTED WITH HIV-1 ON THE INTERVAL OF 40 TO 10,000,000COPIAS / ML AND IS VALIDATED FOR ALL THE SUBTHPOSES OF A, B, C, D, AE, F, G, H, AB, AG, J YK OF GROUP M OF GROUPS NY O.
  • Manufacturer
    CEPHEID AB || Imported by:ROCHEM BIOCARE COLOMBIA || S.A.S

Manufacturer

CEPHEID AB || Imported by:ROCHEM BIOCARE COLOMBIA || S.A.S