Events

Rappel de Model BP7507 OPTI LION EPlus Cassette

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 OPTI Medical Systems, 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
    66105
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0029-2014
  • Date de mise en oeuvre de l'événement
    2013-08-09
  • Date de publication de l'événement
    2013-10-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121489
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Opti lion e-plus cassettes were labeled with an incorrect barcode. the incorrect barcode could perfect the performance of one or more parameters as the product ages. also a customer complaint from a distributor reported that a customer was getting qc failures.
  • Action
    The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: technicalsupport@optimedical.com Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.

Device

Model BP7507 OPTI LION EPlus Cassette
  • Modèle / numéro de série
    Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.
  • Description du dispositif
    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical || Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
  • Manufacturer
    OPTI Medical Systems, Inc

Manufacturer

OPTI Medical Systems, Inc
  • Adresse du fabricant
    OPTI Medical Systems, Inc, 235 Hembree Park Dr, Roswell GA 30076-5738
  • Société-mère du fabricant (2017)
    IDEXX Laboratories, Inc.
  • Source
    USFDA