Events

Rappel de Device Recall SenDx Medical Inc. ABL80FLEX

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 Sendx Medical 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
    61178
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1384-2012
  • Date de mise en oeuvre de l'événement
    2012-01-30
  • Date de publication de l'événement
    2012-04-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107472
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    The product can cause the analyzer to report values outside the published performance specifications for ph, pco2, cna+, ck+, cca2+ and ccl-.
  • Action
    SenDx Medical sent Customers notification letters dated January 30th, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. We have recently become aware of a possible condition in a limited number of ABLBO FLEX analyzers configured with a specific Control PCe lerinted Circuit Board), which can cause the analyzer to report values outside the published performance specifications for pH, pCOz, cNa*, cK*, cCa2* and cCl-. Customers were instructed to immediately implement Alternative 1 or 2 until the signal data PCB is replaced. Alterative I: Stop the use of all affected analyzers until corrective actions can be performed on these analyzers. Alternative 2: Verify proper function of the affected analyzers immediately following every patient sample measurement by measuring a manual QC sample. Customers were asked to complete the fax form acknowledging receipt of the notice and provided a contact for Technical Support at 1-800-736-0600 opt.4.

Device

Device Recall SenDx Medical Inc. ABL80FLEX
  • Modèle / numéro de série
    Model number: 393-839 Serial number(s): 304157, 304160 and 304162 to 305414 for ABL80 FLEX analyzers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    One US consignee in state of OH. Other consignees are international such as Australia, France, Netherlands, Denmark, China, United Kingdom, Turkey, Switzerland, Japan, India, Poland, Spain, and Germany. Distribution list submitted with supporting doc.s
  • Description du dispositif
    SenDx Medical Inc || ABL80FLEX || Blood Gas, pH, Electrolyte, and Metabolite System || The ABL80 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and hematocrit in whole blood. The ABL80 FLEX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Adresse du fabricant
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA