Events

Rappel de Device Recall Multigent Vancomycin Calibrators

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 Microgenics Corp.

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
    60233
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0297-2012
  • Date de mise en oeuvre de l'événement
    2011-06-08
  • Date de publication de l'événement
    2011-11-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104837
  • 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
    Calibrators, drug specific - Product Code DLJ
  • Cause
    Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.
  • Action
    Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken. Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records. The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them. An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342. Questions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.

Device

Device Recall Multigent Vancomycin Calibrators
  • Modèle / numéro de série
    Catalog number: 6E44-01; Lot 59446762, Exp 3/31/12; lot 59391741, Exp 12/31/2011.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) in the state of ILLINOIS
  • Description du dispositif
    Multigent Vancomycin Calibrators; || Manufactured by Microgenics Corp, Fremont, CA. || Distributed by: Abbott Diagnostics, Abbott Park, IL || Product Usage: || The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin || Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.
  • Manufacturer
    Microgenics Corp

Manufacturer

Microgenics Corp
  • Adresse du fabricant
    Microgenics Corp, 46360 Fremont Blvd, Fremont CA 94538
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA