Events

Rappel de TDx/TDxFLx Gentamicin Wedge Reagent

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 Diagnostic International, Ltd..

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
    46146
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0929-2008
  • Date de mise en oeuvre de l'événement
    2007-10-26
  • Date de publication de l'événement
    2008-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66880
  • 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
    Fluorescent Immunoassay Gentamicin - Product Code LCQ
  • Cause
    Incorrect results -- through evaluation of stability, abbott have found a decrease in the calibrator a to f span with these reagents lots, which may produce the following results: - printed error code "span less than min span" - controls out of range. when a control is out of range, patient results should not be reported.
  • Action
    Letters were sent to customers by Federal Express Priority mail on October 26, 2007. Two unique customer letters were sent. One letter was delivered to TDxlTDxFLx customers who received shipment oflots 5ll87Q100 and 51189QI00 and a second letter was delivered to AxSYM customers who received lots 53190QI00 and 53190QI01. Two letters were written because the actions required by the customer differ for the AxSYM and TDxlTDxFLx platforms. TDx/TDxFLx customers " Customer Letter (Product Recall) " Customer Reply Form AxSYM Customers " Customer Letter (Product Correction) " Customer Reply Form The Customers were instructed the following: TDx/TDxFLx Gentamacin Reagents " Discontinue use of and destroy TDx/TDxFLx reagent lots 51187Q 1 00 and 51189QI00. " Document the number of kits discarded for your records. Abbott will provide reimbursement for your destroyed kits. " If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication. AxSYM Gentamicin Reagents " Revise the expiration date for lots 53190Ql 00 and 53190QI0l from 4/12/08 to 11/30/2007. " Run each level of control with each AxSYM Gentamicin sample or batch of samples. " If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.

Device

TDx/TDxFLx Gentamicin Wedge Reagent
  • Modèle / numéro de série
    List # 9512-85 // Lot # 51189Q100 Exp Date 09/17/08
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.
  • Description du dispositif
    Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Diagnostic International, Ltd.

Manufacturer

Abbott Diagnostic International, Ltd.
  • Adresse du fabricant
    Abbott Diagnostic International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617-3009
  • Source
    USFDA