Events

Rappel de Liquid Stable 2Part Homocysteine Reagent

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 Medtest Holdings, 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
    74234
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2063-2016
  • Date de mise en oeuvre de l'événement
    2015-04-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146910
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Cause
    Deterioration in performance of the liquid stable (ls) 2-part homocysteine reagent resulting in under recovery. the manufacturer has indicated that the homocysteine reagent lot listed above shows deterioration in assay performance manifesting itself by under recovery of homocysteine in controls and patient samples. the cause of this deterioration has been attributed to a loss of reductant activity in reagent 1. testing performed indicated that the affected lot is at the limit of acceptable clinical performance. this observation was consistent across the reportable range of the assay. for this reason, do not continue to use affected reagent lot. test data generated to date will be acceptable where validity control specifications have been met.
  • Action
    On 4/3/2015, Urgent Field Safety Notice notifications were sent to the affected customers via email with instructions for identifying and destroying the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

Device

Liquid Stable 2Part Homocysteine Reagent
  • Modèle / numéro de série
    Model: H7575-57 Lot: 416703 Expiration date: 2016-01
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    MI, MN, NJ, IL, NY. US Only.
  • Description du dispositif
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
  • Manufacturer
    Medtest Holdings, Inc.

Manufacturer

Medtest Holdings, Inc.
  • Adresse du fabricant
    Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Société-mère du fabricant (2017)
    Medtest Holdings Inc
  • Source
    USFDA