Events

Avis De Sécurité sur LABType HD DRB1 Typing Test

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 One Lambda, 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
  • 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
    Notice: the following allele specificities are missing from bead 10 in the lot-specific user documents and catalog file for the labtype hd drb1 typing test (catalog id rssoh2b1, lot 009, batches 001-036) and may cause a mistyping: missing allele specificity potential mistype incorrect lot specific user document/cat file and revision drb1*08:42, drb1*11:29, drb1*11:47, drb1*11:63:01 drb1*16:09:02 samples typed as drb1*08:02:01~02:04 may also be mistyped to drb1*08:42 samples typed as drb1*11:39 may also be mistyped to drb1*11:29 samples typed as drb1*11:151 may also be mistyped to drb1*11:63:01 rsso-h2b1-009-ws3-00; revisions 0-4 rsso-h2b1-009-ws-00; revisions 0-4 rsso-h2b1-009-lim-00; revisions 0-4 rsso-h2b1-009-bpi-00; revisions 0-4 rsso-h2b1-0009-cat-00; revisions 0-4.

Device

LABType HD DRB1 Typing Test

Manufacturer

One Lambda, Inc.