Events

Rappel de ETEST

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 BioMerieux SA.

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
    78688
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0265-2018
  • Date de mise en oeuvre de l'événement
    2017-04-13
  • Date de publication de l'événement
    2017-12-19
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160121
  • 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
    Manual antimicrobial susceptibility test systems - Product Code JWY
  • Cause
    Qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520558, 520518) reported. the product behavior could lead to false resistant results.
  • Action
    BioMerieux sent an Urgent Field Safety Notice on April 30, 2017. Short-term Action: Subsidiaries and distributors are required to discard all ETEST¿ OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.

Device

ETEST
  • Modèle / numéro de série
    REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.
  • Description du dispositif
    ETEST OXACILLIN OX 256 WW F100 || In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Adresse du fabricant
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Société-mère du fabricant (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA