Events

Rappel de Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)

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
    64463
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1049-2013
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • Date de publication de l'événement
    2013-04-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-01-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116185
  • 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
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • Cause
    Siemens healthcare diagnostics has initiated a voluntary field action for dimension(r) phos flex(r) reagent due to reagent interaction causing falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated February 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by Customer: 1. Customers with two or more Dimension systems should perform testing of PHOS and EZCR on separate Dimension systems. 2. Customers with only one Dimension system should discontinue use of either PHOS or EZCR on the Dimension system. Please contact your local sales representative to discuss alternate solutions that will best meet the needs of your laboratory. Please complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at (302) 631-8467, to indicate you have received the information. If you have any questions, please contact the Siemens Technical Solutions enter or your local Siemens technical support representative. We apologize for the disruption this situation will cause your laboratory. We are working diligently to resolve this issue with a permanent solution. .

Device

Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)
  • Modèle / numéro de série
    Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Description du dispositif
    Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) || The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA