Field Safety Notices about ACL TOP 300 CTS, HemosIL SynthasIL

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Instrumentation Laboratory Co..

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.

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  • Type of Event
    Field Safety Notice
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Extra notes in the data
  • Reason
    The manufacturer's research has shown that a carryover tool may occur on an instrument in the acl top analyzer family that causes a shortening of the "aptt" time in patient samples and / or control samples when the hemosil synthasil reagent (pn 0020006800) is placed on the same reagent carrier , together with some other hemosil reagents. interference occurs during the liquid height check (liquid height check) that is performed after mounting the supports and depends on the position of the material, the order in which the supports are placed and the order in which the tests are performed. the degree of shortening of coagulation time varies from instrument to instrument and is not reproducible on all instruments. in some cases, this problem manifested as shortening the "aptt" time by more than ten seconds.