Rappel de Device Recall Boule Con Diff US Tri 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 Clinical Diagnostic Solutions.

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
    63096
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0191-2013
  • Date de mise en oeuvre de l'événement
    2011-03-24
  • Date de publication de l'événement
    2012-11-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2014-08-13
  • Source de l'événement
    USFDA
  • 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
    Mixture, hematology quality control - Product Code JPK
  • Cause
    Clinical diagnostic solutions, inc. in plantation, fl recalled boule con diff us tri pack (product part 501-605, lot #1102-575 and 1102-576; product part 501-607, lot #1102-576; and product part 502-012, lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. the recall was initiated due to the receipt of a complai.
  • Action
    Clinical Diagnostic Solutions, Inc. sent a letter dated March 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm istructed the accounts to replace the assay sheet they were currently using with the new assay sheets enclosed. For an unused product they would need to discard. To correct the ranges in their instrument, they would need to scan in the new bar codes specific for their instrument type. For any questions customers were instructed to contact CDE Technical Support atl 800-453-3328. For questions regarding this recall call 954-791-1773.

Device

  • Modèle / numéro de série
    Product Part 502-012, Lot #1102-574
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MS, ND, ND, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI, WV,and WY. Foreign: Brazil and Colombia
  • Description du dispositif
    Boule Con-Diff Hematology Control || For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Clinical Diagnostic Solutions, 1800 Nw 65th Ave Ste 2, Plantation FL 33313-4544
  • Société-mère du fabricant (2017)
  • Source
    USFDA