Events

Rappel de Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO

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
    62987
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0379-2013
  • Date de mise en oeuvre de l'événement
    2012-08-20
  • Date de publication de l'événement
    2012-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112207
  • 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
    In house testing confirmed that ck-ms and insulin claimed in both omni immune and omni immune pro products are displaying reduced stability.
  • Action
    Microgenics Corporation sent a Recall Notification letter dated August 20, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed that immediate attention is required and identify the two affected constituents. The letter contains a list of the affected product with their catalog number, lot number and expiration date and request that the CK-MB and Insulin use be discontinued. The remaining components of the product may be used. Evaluate quality controls according to your laboratory procedures. Retain a copy of the letter for your laboratory records. If the product was forwarded to another laboratory, provide them with a copy of the letter. Complete the attached Recall Response form and return within 5 days. Questions may be directed to 1-800-232-3342.

Device

Device Recall MAS Omni IMMUNE and Omni IMMUNE PRO
  • Modèle / numéro de série
    MAS Onmi IMMUNE: Catalog Number/lot number/ expiration date: OIM-101 - OIM14031 - 31 MAR 2014; OIM-202 - OIM14032 - 31 MAR 2014; OIM-303 - OIM14033 - 31 MAR 2014; OIM-SP - OIM1403S - 31 MAR 2014.  MAS Omni IMMUNE PRO: OPRO-101 - OPRO14031 - 31 MAR 2014; OPRO-201 - OPRO14032 - 31 MAR 2014' OPRO-303 - OPRO14033 - 31 MAR 2014; OPRO-SP - OPRO1403S - 31 MAR 2014.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Germany, Canada and Australia.
  • Description du dispositif
    Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; || Liquid Assayed Integrated Immunoassay Control. || Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. || .
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Adresse du fabricant
    Microgenics Corporation, 44660 Osgood Rd, Fremont CA 94539-6410
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA