Rappel de Device Recall COULTER ACT 5diff Autoloader Hematology Analyzer

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
    Recall
  • ID de l'événement
    58173
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1979-2011
  • Date de mise en oeuvre de l'événement
    2011-02-23
  • Date de publication de l'événement
    2011-04-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-07-16
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    The recall was initiated because beckman coulter identified a problem with occasional unexpectedly high results for rbc, hct, plt and mpv without instrument generated messages, for the first run of a capped patient sample. upon repeat analysis the results are correct. patients could be affected as described below: (1) false high rbc and hct may result in a delay of treatment, or the delivery of.
  • Action
    The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTION" letter dated February 23, 2011 with an enclosed customer response form to all customers who have the affected instruments via US Postal Service (in US). The letter described the product, problem and actions to be taken. The customers were instructed not to analyze specimens using the Autoloader. Instead, analyze their samples uncapped (open vial) using the Manual (Stat) Mode. The end of this notice includes a Quick Reference for Running Manual Samples. For more detailed instructions, please refer to your instrument's Instructions for Use (IFU), part number 624026, Section 8.4 Running Manual (Stat) Samples. An electronic version of the IFU can be found in the instrument's On-Line Help screen as well as the Beckman Coulter web site. For inconsistent data during patient's follow-up, please consider unusual/unanticipated high or elevated platelet levels as possible falsely elevated results due to this failure. An appropriate action for the need to look-back at previous results is at the discretion of the Laboratory Director, given the fact that laboratories have a variety of measures that are employed to ensure the validity of the results. Some of these provisions include delta checks, laboratory protocols for validating results and interaction with physicians. Additionally, the customers were also requested to complete and return the enclosed PRODUCT CORRECTION RESPONSE FORM within ten (10) days via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 31-B06, 11800 S.W. 147th Avenue, PO Box 169015, Miami, FL 33116-9015, or email to: Regulatory.notifications@beckmancoulter.com. For any questions concerning this notice, contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter representative.

Device

  • Modèle / numéro de série
    Serial Numbers(s): All Serial Numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Angola Mexico Australia, Azerbaijan, Bangladesh, Bermuda, Botswana, Bulgaria, China, Cote d'Ivoire, Finland, France, Germany, Ghana, Hong Kong, India, Italy, Mexico, Netherlands, New Zealand, Nigeria, Palestinian, Puerto Rico, Romania, Russian Federation,Saudi Arabia, Slovenia, South Africa, Spain, Switzerland,Taiwan, Tanzania, and Turkey.
  • Description du dispositif
    COULTER AC-T 5diff Autoloader Hematology Analyzer, Part Number: 175356, Serial || Numbers(s): All Serial Numbers || The COULTER ACT-T 5diff Autoloader (AL) hematology analyzer is a 26-parameter, fully automated hematology analyzer, including a five-part leukocyte differential counter, capable of analyzing samples in a closed-vial Autoloader mode or a Manual (Stat) mode (open- or closed-vial).
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
  • Source
    USFDA