Events

Rappel de Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen 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
    73129
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1171-2016
  • Date de mise en oeuvre de l'événement
    2016-01-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143121
  • 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
    Colorimetry, acetaminophen - Product Code LDP
  • Cause
    Crystal formation in the color reagent (r2) when left on board automated analyzers causing samples to under recover.
  • Action
    Sekisui sent an Important Field Correction - Customer Notification letter dated January 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Discard all reagent in house with a current expiration date of 2016-09. 2. Update the expiration on all remaining kits on hand with the new expiration dates provided 3. When adding additional reagent to the analyzer, a new reagent wedge should be used. 4. If crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent. 5. Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will indicate receipt of this Field Correction, act as confirm action of compliance with the actions,and allow for issuance of replacement material for expired product on hand (lots 47677, 47694, 47695). Questions contact Technical Services at 1-800-565-0265 or via email at PEIDiagnosticTechnical@sekisui-dx.com

Device

Device Recall Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Assay
  • Modèle / numéro de série
    Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.
  • Description du dispositif
    Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic || Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml || Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml || In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.
  • 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