Siemens Healthcare Diagnostics, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008), and 638105002 (expired August 14, 2008).
Products Sold
Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).
Siemens Healthcare Diagnostics, Inc. is recalling Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibrati due to The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than ty. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026