Events

Rappel de Device Recall HardyCHROM VRE Agar

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 Hardy Diagnostics.

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
    71577
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2192-2015
  • Date de mise en oeuvre de l'événement
    2015-06-24
  • Date de publication de l'événement
    2015-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138251
  • 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
    Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
  • Cause
    Hardy diagnostics is recalling hardychrom vre agar due to lack of 510(k) clearance.
  • Action
    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com.

Device

Device Recall HardyCHROM VRE Agar
  • Modèle / numéro de série
    Cat No.: G333 Lot No.: H15055
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to one U.S. customer in SC.
  • Description du dispositif
    HardyCHROM VRE Agar-RSR || Cat no: GA333 Lot no: H15055 || Expires: 2015-07-04 || Container type: 15x100mm monoplate || Packaged: 10 plates/sleeve || Storage 2 to 8 degrees C on receipt || Chromogenic medium for stool pathogen screening.
  • Manufacturer
    Hardy Diagnostics

Manufacturer

Hardy Diagnostics
  • Adresse du fabricant
    Hardy Diagnostics, 1430 W Mccoy Ln, Santa Maria CA 93455-1005
  • Société-mère du fabricant (2017)
    Hardy Diagnostics
  • Source
    USFDA