Events

Recall of Device Recall Dimension Clinical Chemistry System Wash

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68848
  • Event Risk Class
    Class 2
  • Event Number
    Z-2238-2014
  • Event Initiated Date
    2014-07-15
  • Event Date Posted
    2014-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128853
  • Notes / Alerts
    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.
  • Extra notes in the data
    Radioimmunoassay (two-site solid phase), ferritin - Product Code JMG
  • Reason
    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
  • Model / Serial
    lot RD41041, exp. 10/13/2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution and Internationally to Canada.
  • Product Description
    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.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA