Events

Avis De Sécurité sur LIFECODES LifeScreen Deluxe (LMX)

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Immucor Transplant Diagnostics, Inc. .

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
    2016-04-22
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The quality control criteria in the lmx product insert (pi) require lmnc to have a negative reported result for all beads. therefore, a false positive result with lmnc invalidates the assay run, and requires the assay to be repeated. we recently identified that the negative control serum (lmnc lot 3003269, expiration date: 12-15-2017), provided with lifecodes lifescreen deluxe (lmx) lot 3003351, may occasionally demonstrate false positive reactivity. internal investigation identified this performance issue to be related to the interaction between lmnc, lmx beads, and conjugate in this particular lot. .

Device

LIFECODES LifeScreen Deluxe (LMX)

Manufacturer

Immucor Transplant Diagnostics, Inc.
  • Société-mère du fabricant (2017)
    Grifols Sa
  • Source
    AMPMDRS