Events

Rappel de Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob

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 Becton Dickinson & Co..

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
    76930
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1876-2017
  • Date de mise en oeuvre de l'événement
    2015-03-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154600
  • 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, non-selective and non-differential - Product Code JSG
  • Cause
    Bd has confirmed that one lot of tsa ii and chocolate agar i-plates may fail to recover haemophilus influenzae 10211 and haemophilus parainfluenza 51505 on the chocolate agar side of the plate. all other qc organisms are correctly recovered.
  • Action
    Recall notification was initiated on March 27, 2015. US customers were contacted via letters sent by UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 100% of non-respondents to verify receipt of the customer letter.

Device

Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II A...
  • Modèle / numéro de série
    Part/Cat No. 221302  Lot / Serial No. 4365741
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA
  • Description du dispositif
    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate || Product Usage: || Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Adresse du fabricant
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA