Events

Rappel de Device Recall reference electrode membranes / A8L8X7 Flex Creatinine 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 Radiometer America 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
    51983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1015-2010
  • Date de mise en oeuvre de l'événement
    2009-03-26
  • Date de publication de l'événement
    2010-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81837
  • 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, enzyme, for clinical use - Product Code CGL
  • Cause
    Analysis of customer data, (for abl 8x7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. these errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.
  • Action
    The recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be placed in the Operators Manual to reflect this new information. The recall notification is also accompanied by an attached response FAX FORM which the customer is asked to complete and to fax back to Radiometer so as to acknowledge receipt of the recall notification letter and the revised insert. Please direct questions to the company TechLine at 1-800¿736¿0600 opt 2.

Device

Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer
  • Modèle / numéro de série
    Part Number: 942-058, Article Number: D711
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.
  • Description du dispositif
    Reference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Adresse du fabricant
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA