Rappel de Tinaquant Hemoglobin A1c Gen.2

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 Roche Diagnostics Operations, 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
    75366
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0395-2017
  • Date de mise en oeuvre de l'événement
    2016-10-04
  • Date de publication de l'événement
    2016-11-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2017-06-05
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Cause
    Roche diagnostics has confirmed elevated qc and patient sample recovery for individual tina-quant¿ hemoglobin a1c gen.2 and tina-quant hemoglobin a1cdx gen.2 cassettes/bottles. this issue occurred over multiple lots. single cassettes/bottles of the reagents are affected. the issue can lead to erroneously high hba1c results. if a patient with known diabetes is affected, an erroneously high hba1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. this can further lead to an increased risk of hypoglycemia. considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded.
  • Action
    On 10/4/2016, URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected Direct Consignees and Distributors via courier. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Direct Consignee Actions Required " Follow the instructions in the Customer Actions for Prevention/Detection of the Issue section of this Urgent Medical Device Correction (UMDC). " Complete the attached fax form (7184-00-1016) and fax it to 1-844-294-7181. " File this Urgent Medical Device Correction (UMDC) for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. Distributor Actions Required " Ensure proper storage conditions (2-8¿C) are maintained for the reagents listed in the table above, per their respective method sheet. " If you have not directly shipped any of the products in the table above, you do not need to distribute the enclosed UMDC to your customers. " If you have directly shipped any of the products in the table above, please distribute the enclosed UMDC 16-157 to those customers. " Complete the attached fax form (7185-00-1016) and fax it to 1-844-294-7181. Questions Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this distributor letter or the enclosed UMDC 16-157.

Device

  • Modèle / numéro de série
    Not applicable
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    Tina-Quant Hemoglobin A1c Gen. 2 || Hemoglobin A1c test || Catalog number 04528123190 / 05401640190
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
  • Source
    USFDA