Events

Rappel de MAS CardioImmune XL Cardiac Marker Control;

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 Corporation.

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
    69670
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0501-2015
  • Date de mise en oeuvre de l'événement
    2014-10-20
  • Date de publication de l'événement
    2014-12-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131305
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Cause
    Mas cardioimmune xl, level 1 (lot cxl16011), is showing vial-to-vial variation for the analytes creatine kinase-mb (ck-mb) and b-type natriuretic peptide-32 (bnp-32).
  • Action
    ThermoFisher sent an Urgent Medical Device Field Corrections dated October 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Foreign customers were sent letters via overnight mail and e-mail. ACTIONS TO BE TAKEN BY THE CUSTOMER: 1. Determine if you are using or have inventory of MAS Cardiolmmune XL, lot CXL16011. 2. Discontinue use and destroy any remaining inventory of MAS Cardiolmmune XL, lot CXL16011 per your local waste ordinances. 3. Retain a copy of this letter for your laboratory records. 4. If you have forwarded kits of MAS Cardiolmmune XL (lot CXL16011) to another laboratory, please provide a copy of this letter to them. 5. Complete the attached Medical Device Field Correction Response Form and return the form within 5 days to Thermo Fisher Scientific Technical Service as instructed in the form below. 6. Please call technical service at 1-800-232-3342, then press option 2, then option 2 or e-mail mas.controls@thermofisher.com to arrange immediate product replacement. If you are a distributor of the product, please contact your affected customer base, advise them of the situation, and provide them with a copy of this letter. You should insert your contact information, e-mail and fax numbers in the Medical Device Field Correction Response Form and request that they return the form to you. You should fill out the distributor section of the attached Medical Device Field Correction Response Form and return the form within 5 days to Thermo Fisher Scientific Technical Service as instructed in the form. Firm intends to try to get a response twice more by mail or telephone to insure we reach all customers. Affected product remaining at firm is quarantined and will be destroyed.

Device

MAS CardioImmune XL Cardiac Marker Control;
  • Modèle / numéro de série
    Model No.: CAI-XL1; Lot Number: CXL16011, Exp. Date: 2016-01-31.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AR, AZ, CA CO, CT, DE, FL GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY., and the countries of Australia, Canada, China, Germany, Guam, Hong Kong and Taiwan.
  • Description du dispositif
    MAS CardioImmune XL Cardiac Marker Control; || Model: CAI-XL1; || intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Adresse du fabricant
    Microgenics Corporation, 46500 Kato Road, Fremont CA 94538
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA