Events

Rappel de Device Recall SeNova Blood Glucose Test Strips

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 CHdiagnostics.

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
    32883
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1546-05
  • Date de mise en oeuvre de l'événement
    2005-03-14
  • Date de publication de l'événement
    2005-09-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41027
  • 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 Dehydrogenase, Glucose - Product Code LFR
  • Cause
    A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
  • Action
    Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.

Device

Device Recall SeNova Blood Glucose Test Strips
  • Modèle / numéro de série
    Lot numbers: 407061, 4071601, 4071901, 4071902, 4072001, 4072002, 4072201, 4072202, 4072801, 4072802, 4072901, 4072902, 4073001; 4080301, 4080302, 4080303, 4080401, 4080402, 4080601, 4081101, 4081102, 4081601, 4081901, 4082001, 4082002, 4082301, 4082501, 4082502, 4082701, 4083101, 4083102, 4090101, 4090201, 4091601, 4091702, 4092101, 4092201, 4092301, 4092401, 4092701, 4092801, 4092901, 4100101, 4100401, 4100402, 4100501, 4100601, 4101101, 4101201, 4101301, 4101401, 4101801, 4102201, 4102502, 4102601, 4102701, 4102801, 4102901, 4110401, 4110501, 4111101, 4111601 and 4111602.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.
  • Description du dispositif
    SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
  • Manufacturer
    CHdiagnostics

Manufacturer

CHdiagnostics
  • Adresse du fabricant
    CHdiagnostics, 1 Carlson Pkwy N, Plymouth MN 55447-4440
  • Source
    USFDA