Events

Rappel de Device Recall DRI Salicylate Serum Tox Assay

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
    74861
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2884-2016
  • Date de mise en oeuvre de l'événement
    2016-07-25
  • Date de publication de l'événement
    2016-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148620
  • 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
    Colorimetry, salicylate - Product Code DKJ
  • Cause
    Some lots of dri salicylate serum tox assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dl.
  • Action
    The firm, Thermo Fisher Scientific, sent an "URGENT MEDICAL DEVICE FIELD ACTION" letter dated July 25, 2016 by regular mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to determine if they are using or have inventory of any of the affected lots; discontinue use and destroy any remaining inventory of affected lots per local wastes ordinances; retain a copy of the letter for laboratory records; if you have forwarded kits of the affected lots, provide a copy of letter to them; and complete and return attached Medical Device Field Action Response Form within 5 days to Thermo Fisher Scientific Technical Service via fax at 1-888-527-8001 (USA toll free), 510-979-5420 (outside of USA) or email to techservice.mgc@thermofisher.com. If you have any questions contact Technical Services at 1-800-232-3342 (USA only) or 510-969-5000 (outside the USA) press option 2 then option 3.

Device

Device Recall DRI Salicylate Serum Tox Assay
  • Modèle / numéro de série
    Lot Number Expiration Date 60704602 DEC 2016; 72035410 JUL 2017; 72208738 FEB 2018; 72409454 OCT 2018.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
  • Description du dispositif
    DRI Salicylate Serum Tox Assay, Catalog number 0977. || Toxicology: || The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Adresse du fabricant
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA