Events

Rappel de Device Recall LifeScan

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 Lifescan 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
    32200
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0887-05
  • Date de mise en oeuvre de l'événement
    2003-11-17
  • Date de publication de l'événement
    2005-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-09-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39361
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • Cause
    A control solution range for the onetouch ultra test strip of 111-150 mg/dl was incorrectly labeled as 97-131 mg/dl.
  • Action
    On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.

Device

Device Recall LifeScan
  • Modèle / numéro de série
    OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.]
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was released for distribution to 30 consignees nationwide. The firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall. Note: This customer received a shipment of 2 Test Strip boxes (2 boxes x 50 strips/box = 100 test strips) as 'free goods' and was most likely for an LifeScan employee in the field. The lot was released from LifeScan's facility in Puerto Rico on May 1, 2003 and received at LifeScan's warehouse in Milpitas, CA on May 16, 2003. From the Milpitas warehouse, this lot was transferred to LifeScan's warehouse in Mechanicsburg, PA where it was received on June 16, 2003. The affected lot was distributed out of the Mechanicsburg, PA warehouse only. The recall product was distributed in the U.S. only, to the following states: AL, DE, FL, IL, IN, MA, MI, MN, MO, NC, NH, NJ, OH, PA, TN, TX, VA and WV. (A second lot was also mislabeled with the incorrect Control Solution range. This lot was manufactured outside of the US and distributed exclusively in Italy.) The total number of government sales/distribution centers that received the recall product = 0.
  • Description du dispositif
    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., || 1000 Gibraltar Drive, Milpitas, CA 95037
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Adresse du fabricant
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA