Events

Rappel de Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325

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 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
    73585
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1596-2016
  • Date de mise en oeuvre de l'événement
    2016-02-24
  • Date de publication de l'événement
    2016-05-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144536
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Cause
    Product may lead to false susceptible results of staphylococcus spp., enterococcus spp., and s. agalactiae to minocycline.
  • Action
    Biomerieux, Inc. sent an Urgent Notice Product Correction on February 24, 2016, to all affected customers. The recalling firm notified their foreign subsidiary of the Field Safety Corrective Action (FSCA) by email. The local subsidiary in the country impacted has informed users impacted and provided instructions to resolve the issue. Customers were instructed to confirm the Field Safety Corrective Action letter has been distributed and reviewed by all appropriate personnel within their organization. ¿ For the referenced test kit (VITEK¿ 2 ASTP605, Lot 485368220), refrain from reporting Minocycline (MNO) results for any organism until a new lot is implemented in your laboratory.¿ o Please note that a bioART rule can be created to suppress the analysis/reporting of Minocycline (reference VITEK¿ 2 Online Software User Manual). The bioART rule can be disabled upon implementation of a new ASTP605 lot number. Customers were instructed tostore the letter with their bioM¿rieux instrument documentation. ¿ Complete the attached Acknowledgement Form and return it to their local bioM¿rieux representative. For questions regarding this recall call 314-731-8526.

Device

Device Recall VITEK 2 Gram Positive Susceptibility Test Cards ASTP605 REF 22 325
  • Modèle / numéro de série
    Lot/Serial: 485368220 Expiry: 12-JAN-17
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution to China  Taiwan region; No US/military/government distribution.
  • Description du dispositif
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. || VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
  • Manufacturer
    Biomerieux Inc

Manufacturer

Biomerieux Inc
  • Adresse du fabricant
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • Société-mère du fabricant (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA