Events

Rappel de Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes

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 Accriva Diagnostics Inc., dba ITC, dba Accumetrics.

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
    73949
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1720-2016
  • Date de mise en oeuvre de l'événement
    2016-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145590
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Cause
    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing aptt test to either have an error code or an erroneously high result.
  • Action
    Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: Fieldaction16-007@accriva.com

Device

Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes
  • Modèle / numéro de série
    Lot #B6JCA012
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
  • Description du dispositif
    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
  • Manufacturer
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics

Manufacturer

Accriva Diagnostics Inc., dba ITC, dba Accumetrics
  • Adresse du fabricant
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics, 6260 Sequence Dr, San Diego CA 92121-4358
  • Société-mère du fabricant (2017)
    Werfenlife Sa.
  • Source
    USFDA