Events

Rappel de Device Recall VITROS Immunodiagnostics Products HBsAg Reagent Pack

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ortho-Clinical Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    37528
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0747-2007
  • Date de mise en oeuvre de l'événement
    2007-02-01
  • Date de publication de l'événement
    2007-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50684
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    HBsAg Reagent Pack - Product Code LOM
  • Cause
    Complaints of an increase in ''reactive'' results with patient samples collected in sodium citrate or edta plasma collection tubes when using these lots of vitros hbsag reagent pack compared to samples collected in other tube types.
  • Action
    On 2/01/07, all US end-user consignees who received the VITROS HBsAg Reagent Packs, were informed of this issue by Federal Express overnight letter, and informed that they may continue to use their current lot of VITROS HBsAg Reagent Pack providing that they followed the instructions in the letter. INSTRUCTIONS: Please do the following if you choose to continue using sodium citrate and/or EDTA plasma collection tubes: - Do not freeze samples collected in sodium citrate or EDTA plasma collection tubes prior to processing the assay. - Process samples collected into sodium citrate plasma tubes within 12 hrs. of collection. -Continue to perform supplemental testing to confirm all HBsAg results that repeat as 'Borderline' or 'Reactive', as directed in the Package Insert. - Complete and return the attached Confirmation of Receipt Form upon receipt of this notification. - Forward the information in this notification if you have distributed the product outside your facility

Device

Device Recall VITROS Immunodiagnostics Products HBsAg Reagent Pack
  • Modèle / numéro de série
    Lots 6000 and 6030 thru 6120
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla.
  • Description du dispositif
    VITROS¿ Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Adresse du fabricant
    Ortho-Clinical Diagnostics, Forest Farm Estate, Whitechurch, Cardiff United Kingdom
  • Source
    USFDA