Events

Rappel de Device Recall Sysmex

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 Sysmex America 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
    74654
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2770-2016
  • Date de mise en oeuvre de l'événement
    2016-07-01
  • Date de publication de l'événement
    2016-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148122
  • 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
    Stains, hematology - Product Code KQC
  • Cause
    There is a potential that fluorescent platelet (plt-f) and immature platelet fraction (ipf%) results performed using the recalled lots may exhibit lower than expected plt-f and ipf values. the issue may be recognized by a large discrepancy between the impedance platelet (plt-i) value and a false low plt-f value. in most cases, the falsely decreased plt-f results displayed a "plt abn scattergram" message with asterisks beside the results indicating the data is unreliable. in rare instances, platelet flags may be absent. the plt-i counts are unaffected. the plt-f is a reflex test used to confirm plt-i results due to flagging or low values. as such, the likely impact to patient results is low. affected results display a discrepancy between the plt-i and plt-f, with lower than expected plt-f results that do not match the patient's clinical picture.
  • Action
    Sysmex sent a Product Notification Letter dated August 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . Customers were instructed to cease use and discard the affected lots, and reply to Sysmex America, Inc. using the provided fax-back form. An updated Product Notification (Attachment 1) was mailed to all XN-Series customers on August 12, 2016 informing them of the additional recalled lots. This notification included the phone number for the Technical Assistance Center at 1-888-879-7639 in the U.S., and 1-888-679-7639 in Canada.

Device

Device Recall Sysmex
  • Modèle / numéro de série
    Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiration date 9/2/2016 Lot number A5042, Expiration date 9/2/2016 Lot number A5044, Expiration date 10/2/2016 Lot number A5046, Expiration date 11/9/2016 Lot number A5047, Expiration date 11/17/2016 Lot number A5048, Expiration date 11/17/2016 Lot number A5049, Expiration date 11/26/2016 Lot number A5050, Expiration date 11/26/2016 Lot number A5055, Expiration date 12/24/2016
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.
  • Description du dispositif
    Fluorocell PLT reagent, Catalog #CD994563 || Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
  • Manufacturer
    Sysmex America Inc

Manufacturer

Sysmex America Inc
  • Adresse du fabricant
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • Société-mère du fabricant (2017)
    Sysmex Corp.
  • Source
    USFDA