Events

Rappel de Device Recall VersaTREK Automated Microbial Detection System

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 Remel 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
    71291
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1842-2015
  • Date de mise en oeuvre de l'événement
    2015-05-19
  • Date de publication de l'événement
    2015-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137730
  • 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, blood culturing - Product Code MDB
  • Cause
    Use of the recalled product may result in false positive reports.
  • Action
    Remel, Inc. a part of Thermo Scientific sent a Product Correction Notification dated May 19, 2015, to all affected customers. The notification states the problem with the device and that the recalling firm's Technical Services department will be contacting the customer to schedule a field service of the device to correct the issue. Customers were instructed to notify any personnel who need to be notified of the potential for a false positive resulting from rare inconsistent barometric pressure readings. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice of the affected product. If product was further distributed customers were instructed to contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-642-7029. For questions regarding this recall call 770-409-0713.

Device

Device Recall VersaTREK Automated Microbial Detection System
  • Modèle / numéro de série
    Serial numbers: 0169050501141020, 0169059801141031, 0169064701141210, 0169066801150105, 2200X1113, 2215X1113, 2236X1213, 2244X1213, 2272X0214, 2273X0214, 2274X0214, 2275X0214, 2298X0714, 2299X0714, 2300X0714, 2301X0714, 2303X0714, 2304X0714, 2326X0814, 2327X0814, and 2328X0814;
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) to states of AZ, CO, FL, GA, IA, ID, LA, MI, MO, PR, TN, TX, VA, and WA and the countries of Canada, People's Republic of China, Egypt, Finland, France, Indonesia, Israel, Jordan, Kenya, Republic of Korea, Latvia, Romania, Russia, Spain, Thailand, United Kingdom, Uruguay, and Vietnam.
  • Description du dispositif
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. || The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
  • Manufacturer
    Remel Inc

Manufacturer

Remel Inc
  • Adresse du fabricant
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA