Events

Rappel de Device Recall Dimension Clinical Chemistry System Wash

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
    68848
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2238-2014
  • Date de mise en oeuvre de l'événement
    2014-07-15
  • Date de publication de l'événement
    2014-08-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128853
  • 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
    Radioimmunoassay (two-site solid phase), ferritin - Product Code JMG
  • Cause
    Siemens healthcare diagnostics has received complaints for the dimension chemistry wash (rd701) of qc and patient sample result accuracy shifts on troponin i, ctni (rf421c), ltni (rf521c); free t4, ft4 (rf410); thyroid stimulating hormone, tsh (rf412); and n-terminal pro-brain natriuretic peptide, pbnp (rf423a) and lpbn (rf523a) when using dimension® chemistry wash lot rd41041. internal inv.
  • Action
    Siemens sent an Urgent Medical Device Recall letter dated July 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer: 1. Immediately discontinue use and discard all inventory of Chemistry Wash lot RD41041. If this lot was never in use on the instrument, no further action is needed. If this lot has been in use, continue with steps 2 through 5. 2. Place an alternate lot of Chemistry Wash on the Dimension system. 3. Prime the new bottle of Chemistry Wash 30 times. 4. Recalibrate the CTNI, LTNI, TSH, FT4, PBNP and/or LPBN assays using the alternate lot of Chemistry Wash on board. 5. For the listed assays, process Quality Control every 8 hours. Actions to be taken by Siemens: Your Customer Service Engineer will be making a visit to decontaminate the system if you have used lot RD41041. This process will take approximately two hours. Once decontamination has been completed, process and evaluate quality control. Resume routine QC testing frequency according to your standard laboratory practice. Siemens is shipping replacement product at no charge for all orders filled with lot RD41041. If you have questions about your replacement shipment, please contact Customer Service at (888) 588-3916. Please complete the attached form and fax it to (302) 631-8467 to indicate that you have received this information. Please retain this letter with your laboratory records. Please forward this letter to anyone to whom you may have provided this product. We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall Dimension Clinical Chemistry System Wash
  • Modèle / numéro de série
    lot RD41041, exp. 10/13/2014
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution and Internationally to Canada.
  • Description du dispositif
    Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
  • 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