Class 3 Device Recall Siemens Stratus(R) CS Acute Care(TM) Ddimer Calibrator (DDM CalPak)

• Date Initiated by Firm: June 07, 2012
• Date Posted: August 28, 2012
• Recall Status: Terminated on January 16, 2014
• Recall Number: Z-2283-2012
• Recall Event ID: 62712
• 510(K)Number: K063356
• Product Classification: Fibrinogen and fibrin split products, antigen, antiserum, control - Product Code DAP
• Product: 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
• Code Information: DDMR CalPak lots 502058002, exp 2012/11/23 and 501318002, exp 2012/08/10
• FEI Number: 2517506
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr Ms 514; PO BOX 6101; Newark DE 19702-2466
• For Additional Information Contact: Robert J. King; 800-441-9250
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 786 cartons
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DAP