Events

Rappel de Device Recall AxSYM Total BhCG

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 Abbott Health Products, 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
    29623
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1436-04
  • Date de mise en oeuvre de l'événement
    2004-07-07
  • Date de publication de l'événement
    2004-09-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-12-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34239
  • 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
    Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
  • Cause
    Complaints have been received for axsym total b-hcg reagents lots 17202q100, 17556q100 and 17387q100 failing calibrations.
  • Action
    Device recall letters dated 7/7/04 were sent to all customers. Customers were instructed to identify if they have used, are currently using, or have inventory of the AxSYM Total B-hCG Reagent lots. Discontinue use of and destroy any remaining inventory of the lots according to their laboratory procedures. Record the quantity currently in their facility that will be destroyed on the attached reply form and fax the form to Abbott at 1-800-777-0051 (U.S. only). Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.

Device

Device Recall AxSYM Total BhCG
  • Modèle / numéro de série
    Lots numbers: 17202Q100 (expiration date 09/23/2004),  17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was nationwide to Laboratories and to the following government accounts: Logistic Div USAMEDAC Lab, Fort Drum, NY Keller Army Hospital Med Sup, West Point, NY VA MED CTR SUP SRV, Milwaukee, WI Weed Army Comm Hosp Lab, Fort Irwin, CA Shaw AFB 20th MDSS SGSL, Shaw AFB, SC Contr Officer, Lemoore, CA Naval Hosp, Pensacola, FL MEDCL CTR FED Prisoners, Springfield, MO Foreign countries: Japan, Singapore, Australia, New Zealand, Dominican Republic, San Salvador, Pakistan, Thailand, Honduras, Canada, Taiwan and Ge
  • Description du dispositif
    AxSYM Total B-hCG Reagent Pack
  • Manufacturer
    Abbott Health Products, Inc.

Manufacturer

Abbott Health Products, Inc.
  • Adresse du fabricant
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA