Events

Rappel de Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

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 Haemoscope Division of Haemonetics Corp.

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
    58847
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2742-2011
  • Date de mise en oeuvre de l'événement
    2011-03-04
  • Date de publication de l'événement
    2011-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100407
  • 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
    Hematology Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
  • Cause
    Haemoscope received a report that during the process of validation, level ii qc was running with an out-of-range low ma (maximum amplitude).
  • Action
    Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge. For additional information please contact Haemoscope at 847-588-0453, ext-217 .

Device

Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit
  • Modèle / numéro de série
    part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
  • Description du dispositif
    TEG Hemostasis System Level II Control: || Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series || Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
  • Manufacturer
    Haemoscope Division of Haemonetics Corp

Manufacturer

Haemoscope Division of Haemonetics Corp
  • Adresse du fabricant
    Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
  • Société-mère du fabricant (2017)
    Haemonetics Corporation
  • Source
    USFDA