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.
FDA Recall Z-1555-2009 · Posted None
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2008-04-28
Date Terminated2009-07-14
Product Quantity4415 cartons
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
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide Distribution - including United States, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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