Events

Rappel de Device Recall Ammonia L3K Assay

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 Sekisui Diagnostics P.E.I. Inc..

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
    75818
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1078-2017
  • Date de mise en oeuvre de l'événement
    2016-11-29
  • Date de publication de l'événement
    2017-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151386
  • 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
    Enzymatic method, ammonia - Product Code JIF
  • Cause
    Certain lots are showing an atypical decrease in optical density (od) over time, which may result in an impact to performance at the high end of the linear range.
  • Action
    Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K¿ reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK¿ from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email PEIDiagnosticTechnical@sekisui-dx.com.

Device

Device Recall Ammonia L3K Assay
  • Modèle / numéro de série
    Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
  • Description du dispositif
    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 || For the IN VITRO quantitative measurement of ammonia concentration in plasma
  • Manufacturer
    Sekisui Diagnostics P.E.I. Inc.

Manufacturer

Sekisui Diagnostics P.E.I. Inc.
  • Adresse du fabricant
    Sekisui Diagnostics P.E.I. Inc., 70 Watts Ave, Charlottetown Canada
  • Société-mère du fabricant (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA