Rappel de Device Recall Siemens ChekStix Positive and Negative Control Strips for Urine Chemistry

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 Siemens Healthcare Diagnostics 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
    63809
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0638-2013
  • Date de mise en oeuvre de l'événement
    2012-11-21
  • Date de publication de l'événement
    2013-01-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2014-11-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • Cause
    When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿c (77¿f).
  • Action
    Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas¿ and Chek-Stix¿ Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25¿C (77¿F) or lower. If the operating temperature is greater than 25¿C and lower than 30¿C (77¿F and 86¿F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.

Device

  • Modèle / numéro de série
    Carton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
  • Description du dispositif
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry || (Distributed OUS Only) || Catalog Number: 1360L || Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Société-mère du fabricant (2017)
  • Source
    USFDA