Recall Z-1555-2009
Siemens Healthcare Diagnostics, Inc. · initiated April 28, 2008
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.
Codes / lots: Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).
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: Labeling False and Misleading
Action taken
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.
Details
- Recall number
- Z-1555-2009
- Initiated
- April 28, 2008
- Terminated
- July 14, 2009
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Quantity
- 4415 cartons
- Distribution
- Worldwide Distribution - including United States, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE