Events

Rappel de Device Recall ST AIAPACK PROG II

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 Tosoh Bioscience 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
    79176
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0825-2018
  • Date de mise en oeuvre de l'événement
    2018-02-13
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161514
  • 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
    Radioimmunoassay, progesterone - Product Code JLS
  • Cause
    Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of dhea-s, a metabolite of the dhea (dehydroepiandrosterone) supplement.
  • Action
    The assays identified in the above table must not be used to report results for patients who are taking DHEA supplements. " For patients that are taking DHEA supplements, an alternative testing method which is not expected to show cross reactivity to DHEA-S should be used such as Liquid Chromatography-Mass Spectroscopy (LCMS). " Please review the information in this Urgent Medical Device Recall with your Medical Director and/or Lab Director, as soon as possible. " Continue to use the Progesterone Assays for patients who are not receiving DHEA supplements or therapy. " Complete and return the attached Urgent Medical Device Recall Acknowledgement Form within 15-days. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at 1(800) 248-6764 or email Bernadette.OConnell@tosoh.com. " Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at 1(800) 248-6764, or by email at Bernadette.OConnell@tosoh.com. We will be available to answer any questions Monday - Friday, from 8:00 AM to 5:00 PM (PST).

Device

Device Recall ST AIAPACK PROG II
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • Adresse du fabricant
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • Société-mère du fabricant (2017)
    Tosoh Corp.
  • Source
    USFDA