Events

Rappel de ELECSYS CrossLaps/Serum Immunoassay

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 Roche Diagnostics Operations, 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
    65163
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1727-2013
  • Date de mise en oeuvre de l'événement
    2013-04-25
  • Date de publication de l'événement
    2013-07-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118059
  • 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
    Column chromatography & color development, hydroxyproline - Product Code JMM
  • Cause
    Roche diagnostics internal investigations in r&d; have shown that the claims for biotin interference and the sample stability given in the elecsys ¿-crosslaps (¿-cl) assay package insert version 5, could not be reproduced. the ¿-crosslaps test results contribute to the monitoring of antiresorptive therapy. false low or false normal results may lead to delayed diagnosis and treatment of osteoporosi.
  • Action
    The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" (UMDC)letter dated May 2, 2013, to its consignees/customers via UPS Ground. The letter describes the product, problem and actions to be taken. The consignees/customers were instructed to apply the correct sample storage conditions as stated in the UMDC and to inform all relevant parties about the correct biotin interference claim. The consignees/customers were instructed to keep the UMDC on file for reference until the revised package insert is available. The consignees/customers were asked to complete and return a form via fax (1-888-943-4205). Consignees/customers were instructed to call Roche Diagnostics Technical Support, 24 hours a day, seven days a week, at 1-800-428-2336 if they had any questions about the recall. Non-responding accounts are monitored on an ongoing basis.

Device

ELECSYS CrossLaps/Serum Immunoassay
  • Modèle / numéro de série
    All lot numbers
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA.
  • Description du dispositif
    B-CrossLaps/serum (B-CTx in serum) || REF 11972308 160 || 100 tests || Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA