Events

Rappel de Device Recall ACON Mission Breath Alcohol Detector

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 Acon Laboratories, 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
    71550
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2322-2015
  • Date de mise en oeuvre de l'événement
    2015-06-17
  • Date de publication de l'événement
    2015-07-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138181
  • 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
    Devices, breath trapping, alcohol - Product Code DJZ
  • Cause
    Acon laboratories, inc. is recalling mission breath alcohol detector due to a labeling amendment.
  • Action
    On 06/17/15 the firm sent out customer notification letters to their distributors. The letter identified the affected product, problem and actions to be taken. In the letter the firm requests that Mission Breath Alcohol Detectors be quarantined. The firm asks that distributor complete the "fax back" form to allow for the return of unexpired product for a replacement. Once the form is received the firm is going to issue a return authorization number as well as provide a return label. The contact noted in the letter is Qiyi Xie MD, MPH, Sr. Officer Regulatory and Clinical Affairs at 858-857-8011.

Device

Device Recall ACON Mission Breath Alcohol Detector
  • Modèle / numéro de série
    -BAD4040003 (48 kits) -BAD4080006 (59 kits) -BAD5010010/BAD5040013/BAD5010011 (total of 1,176 kits)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    U.S. Nationwide Distribution in the states of: NY, CA, FL, VA, LA, NJ, MN, PA, MI, OH, TX, VA, UT, AL, and GA
  • Description du dispositif
    Mission || -Breath Alcohol Detector || -15 tests || - 0.08% BAC || - Blow bags included || Product Usage: || The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
  • Manufacturer
    Acon Laboratories, Inc.

Manufacturer

Acon Laboratories, Inc.
  • Adresse du fabricant
    Acon Laboratories, Inc., 10125 Mesa Rim Rd, San Diego CA 92121-2915
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA