Rappel de Device Recall Coulter Lyse S III diff Lytic

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 Beckman Coulter 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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Red-Cell lysing products - Product Code GGK
  • Cause
    The recall was initiated by beckman coulter because the coulter lyse iii diff lytic reagent lot number 101554f was released for distribution to customers between november 17 and december 1, 2010 prior to completion of qc testing.
  • Action
    Beckman Coulter sent a Product Corrective Action ( PCA) letter dated December 28, 2010, to all affected consignees with an attached PCA Response form via US Postal Service for US Customers) who purchased the Coulter Lyse S III diff Lytic Lot # 101554F. The letter provides customers with an explanation of the problem identified and an action to be taken. If customers currently had any of the lot mentioned above in their laboratory, they were asked to discontinue use and discard remaining product according to their laboratory chemical safety procedures. And to complete and return the enclosed response form within 10 days to acknowledge that they received this notice and are taking appropriate action. For the population at most risk, there is no serious consequences and only remote probability of injury and medically reversible consequences due by the small change for Hgb and WBC results. Consignees were also asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Technical questions regarding this Product Corrective Action were directed to Beckman Coulter Customer Service at( 800) -526-7694 in the United States and Canada.


  • Modèle / numéro de série
    Lot Number: 101554F
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distrubution-- USA ( nationwide) including states of : AL, AR, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI, & WV and country of Canada.
  • Description du dispositif
    COULTER LYSE S III diff Lytic Part Number: 8546796. || COULTER LYSE S III diff Lytic Reagent For use as an erythrocyte lytic agent for the quantitative determination of hemoglobin and for leukocyte counting and sizing on COULTER GEN S, MAXM, HmX, LH500, LH 750, and LH 780 hematology analyzers. Use with only ISOTON III or LH Series diluent. Refer to your instrument product manuals and/or online help, as applicable.
  • Manufacturer


  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
  • Source