Events

Avis De Sécurité sur ACL TOP 300 CTS, HemosIL SynthasIL

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Instrumentation Laboratory Co..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date de publication de l'événement
    2013-10-23
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2013/10/23/%d0%b2%d0%b0%d0%b6%d0%bd%d0%be-%d0%be%d0%b1%d0%b0%d0%b2%d0%b5%d1%88%d1%82%d0%b5%d1%9a%d0%b5-%d0%be-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d0%bc-%d1%81%d1%80%d0%b5%d0%b4%d1%81/
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.

Device

ACL TOP 300 CTS, HemosIL SynthasIL

Manufacturer

Instrumentation Laboratory Co.