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
    29985
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0006-05
  • Date de mise en oeuvre de l'événement
    2004-08-24
  • Date de publication de l'événement
    2004-10-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34915
  • 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
    Assay may give elevated patients results.
  • Action
    Device recall letters dated 8/24/2004 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 (US 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
    Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04
  • 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: 375th MEDCL GRP, Scott AFB, IL, Logistic Div USA MEDDAC, Fort Drum, NY, MED MAT SVC SGSL, Colorado Springs, CO, Naval Hosp RCVG OFCR, Charleston, SC, Keller Army Hosp MED SUP, West Point, NY, 325 MED GRP SGSL, Tyndall AFB, FL, VA Hosp Whse 90D, Miami, FL, VA MED CTR, Danville, IL, VA MED CTR, Amarillo, TX, VA MED CTR, Columbia, SC, VA MED CTR, Milwaukee, WI, 1st Med GRP, Langley AFB, VA, VA MEDCL CTR, Charleston, SC, VA MEDCL CTR, Albuquerque, NM, USH S IND Hosp., Lawton, OK, POST MED SP HSXA LOG, Fort Belvoir, VA, 366 MEDCL GRP SGSL, MTN HOME AFB, ID, Dover AFB FM, Dover AFB, DE, WEED Army COMM Hosp, Fort Irwin, CA, SHAW AFB 20th MDS SGSL, Shaw AFB, SC, William W Hasting Hosp, Tahlequah, OK, USPHS San Fidel, San Fidel, NM, Cherokee Indian Hosp, Cherokee, NC, Mount Edgecumbe Hosp, Sitka, Ak, CONTR OFFICER, Lemore, CA, FOREST CNTY POTAWATOMI, Crandon, WI, Naval Hosp, Pensacola, FL, Naval Hosp Comm OFFR, Great Lakes, IL, CONTR OFFICER, Bremerton, WA, MEDCL CTR FED PRISIONERS, Springfield, MO, PHS INDIAN HOSP, Fort Yates, ND Foreign countries: Singapore, Australia, New Zealand, Costa Rica, Ecuador, Chile, Germany, Canada, Mexico, Barbados, St. Vincent and Bermuda.
  • Description du dispositif
    AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
  • 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