Events

Recall of Device Recall Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges

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
    58379
  • Event Risk Class
    Class 2
  • Event Number
    Z-2154-2011
  • Event Initiated Date
    2010-06-10
  • Event Date Posted
    2011-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99240
  • 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
    Enzymatic, method, creatinine - Product Code JFY
  • Reason
    Results may be falsely depressed up to 0.4 mg/dl or falsely elevated up to 0.6 mg/dl across the assay range.
  • Action
    Siemens sent an Urgent Field Safety Notice letter dated June 2010 to all Dimension Vista(R) ECREA customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to: Discontinue use of ECREA method and transition to the Dimension(R) Jaffe creatinine (CREA) method. To notify anyone to whom they may have distributed the product. Complete and return the Effectiveness Check Questionnaire attached to the letter by fax to (302) 631-8467. For questions regarding this recall call (302) 631-6299.

Device

Device Recall Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges
  • Model / Serial
    Catalog number K1270 - lot numbers 09224AA, 09286AA, 09350AC, 10011AF, 10047AA, 10089AC, 10089AD, 10131AC and 10131AD.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - including AL, AZ, CA, CO, DE, FL, GA, ID, IL, IA, MD, MA, MI, MT, NH, NJ, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI.
  • Product Description
    Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System || The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA