Events

Rappel de Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent

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
    60982
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1043-2012
  • Date de mise en oeuvre de l'événement
    2011-12-19
  • Date de publication de l'événement
    2012-02-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106986
  • 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
    Test, time, partial thromboplastin - Product Code GGW
  • Cause
    The listed lots of dade(r) actin(r) fsl reagent show an increase in heparin sensitivity over the shelf life which is demonstrated by testing with dade(r) citrol(r) heparin control, low and high.
  • Action
    Siemens sent an Urgent Field Safety Notice letter dated December 2011 to all customers of the affected lots. The letter identified the product, description of problem, and actions to be taken by the user. Dade¿ Actin¿ FSL customers were instructed to exercise one of two options: 1) If customers would like to continue working with their Dade(R) Actin FSL reagent lot (if one of the impacted lots) they must verify on a regular basis (monthly) that their therapeutic range is still valid, e.g. by using a Heparin containing control. In the case that it is not valid, they are to adjust their existing therapeutic range or establish a new one. 2) If customers decide not to continue working with the Dade(R) Actin(R) reagent lot (if one of the impacted lots) they are to contact their Siemens representative at 1-800-242-3233, option 5, for a replacement lot. Once they have established a new normal, therapeutic, and quality control ranges, they are to discard the remainder of the old lot. Customers were advised to complete the response form included to confirm receipt of Safety Notice and fax back to (302) 631-8467. If you have any questions or concerns, please contact the Technical Solutions Center at 1-800-242-3233, option 1.

Device

Device Recall Dade(R) Actin(R) FSL Activated PTT Reagent
  • Modèle / numéro de série
    Catalog number B4219-1J, lot numbers 537360, 537374 and 547301; catalog number B4219-1, lot numbers 537360A, 537366, 537374A, 547301A, and 547306; catalog number B4219-2J, lot numbers 534362 and 537365; and catalog number B4219-2, lot numbers 537362A and 537365A.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Mongolia, Netherlands, Oman, Philippines, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.
  • Description du dispositif
    Dade(R) Actin(R) FSL Activated PTT Reagent || Product Usage: || Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent with increased sensitivity to lupus-like inhibitors for use in the determination of the activated partial thromboplastin time (APTT) and related coagulation procedures.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA