Events

Recall of Device Recall Siemens Stratus(R) CS Acute Care(TM) Ddimer Calibrator (DDM CalPak)

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
    62712
  • Event Risk Class
    Class 3
  • Event Number
    Z-2283-2012
  • Event Initiated Date
    2012-06-07
  • Event Date Posted
    2012-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111478
  • 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
    Fibrinogen and fibrin split products, antigen, antiserum, control - Product Code DAP
  • Reason
    Siemens has confirmed that the stratus(r) cs acute care(tm) d-dimer calpak calibrator lots 502058002 and 501318002 may exhibit slope or calcv error messages (instrument errors), which indicate calibration failures.
  • Action
    SIEMENS sent an Urgent Field Safety Notice dated June 7, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included a response form to be faxed to the recalling firm at 302-631-8467 by the consignee. If customers experienced calibration failures, they were instructed to contact the Siemens Technical Solutions Center at 800-405-6473 for assistance. Customers were also asked to forward the notification to anyone to whom they may have distributed the affected product. For questions regarding this recall call 302-631-6311.

Device

Device Recall Siemens Stratus(R) CS Acute Care(TM) Ddimer Calibrator (DDM CalPak)
  • Model / Serial
    DDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - USA including AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY.
  • Product Description
    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 || The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method
  • 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