Events

Field Safety Notices about INSTI® HIV-1/HIV-2 Antibody Test

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Laboratoires NEPHROTEK.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-02-02
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Three false negative results were reported by a customer when testing three different patient samples with insti hiv-1/hiv-2 antibody test kit from lot 1512ba033. all customers that received the insti hiv-1/hiv-2 antibody test kit lot 1512ba033 were initially advised (by means of field safety notice ai002.17.N, dated 19 january 2017) to quarantine any kits from this lot remaining in their inventory. biolytical laboratories inc. the manufacturer of insti hiv-1/hiv-2 antibody test conducted a thorough investigation using the insti kits from lot 1512ba033 that were retained at the manufacturer’s facility and sample kits returned by the complainant. sera samples of the patients that tested false negative with insti kits from lot 1512ba033 were also used by biolytical laboratories inc. to conduct the investigation. .

Device

INSTI® HIV-1/HIV-2 Antibody Test

Manufacturer

Laboratoires NEPHROTEK