Events

Avis De Sécurité sur VITEK® 2 card pouches

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 bioMérieux.

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
    A potential issue was identified related to the white pouch which contains vitek® 2 test cards for the referenced product lots. biomérieux has determined that the integrity of some of the vitek® 2 test card pouches may be compromised. based on our investigation, a compromised test card pouch can impact card reagents due to the entry of moisture. the white pouch is composed of five (5) layers of material, four (4) of which are clear. all five layers must be compromised for a pouch to potentially allow moisture to enter the pouch. upon visual inspection of the pouch, you may notice a small puncture or tear in the packaging at the "stitch seal" (see figure a immediately below). per product labeling, do not use the card if the pouch (the white protective package cover) is damaged. based on internal testing, approximately 20% of card pouches exhibited a visual defect; the majority of card pouches with this visual defect maintained pouch integrity, i.E. at least one of the five material layers remained intact. however, 1 in 200 (0.5%) card pouches that passed careful visual inspection failed further integrity tests, indicating the potential for entry of moisture. .

Device

VITEK® 2 card pouches
  • Modèle / numéro de série
    21341 GN ID Test Kit 20 Cards 2410047203 12-JAN-2018 413062 AST-N208 Test Kit 20 Cards 5780255103 08-AUG-18 414967 AST-YS07 Test Kit 20 Cards 2870221203 05-JUL-18
  • Manufacturer
    bioMérieux

Manufacturer

bioMérieux