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U.S. Department of Health and Human Services

Class 2 Device Recall Stratus CS Acute Care Troponin I CalPak

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  Class 2 Device Recall Stratus CS Acute Care Troponin I CalPak see related information
Date Initiated by Firm April 28, 2008
Create Date June 25, 2015
Recall Status1 Terminated 3 on July 14, 2009
Recall Number Z-1555-2009
Recall Event ID 52007
510(K)Number K051650  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product Siemens Stratus CS Acute Care Troponin I CalPak.

In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer.
Code Information Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information Contact Technical Solutions Center
800-405-6473
Manufacturer Reason
for Recall		 The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that
FDA Determined
Cause 2		 Labeling False and Misleading
Action Siemens Healthcare Diagnostics, Inc. issued an Urgent Field Safety Notice dated April 29, 2008 to all affected customers instructing them to discontinue use of 3 CalPak lots and reduce the shelf-life for the remaining lots. For further information, contact Siemens Healthcare Diagnostics, Inc. at 1-302-631-7672.
Quantity in Commerce 4415 cartons
Distribution Worldwide Distribution - including United States, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal.
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 = MMI and Original Applicant = DADE BEHRING, INC.
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