Events

Rappel de Device Recall BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B

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
    71602
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2277-2015
  • Date de mise en oeuvre de l'événement
    2015-06-26
  • Date de publication de l'événement
    2015-07-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138503
  • 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 macconkey agar with ciprofloxacin, brain heart infusion broth with ciprofloxacin 1 ug, mdr acinetobacter, bea with azide and vancomycin, bea agar with vancomycin, gentamicin, and amphotericin b, bea broth with vancomycin, and vre broth 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 discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com. Follow-up calls will be made to customers who do not respond.

Device

Device Recall BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B
  • Modèle / numéro de série
    Lot number: 15105 Cat no. G107
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide Distribution and the country of: Canada
  • Description du dispositif
    Hardy Diagnostics || BEA Agar with VGA || container type: 15x100mm monoplate || packaged: 10 places/sleeve || Product Usage: || BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).
  • 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