FDA Medical Device Recalls (openFDA)
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 number
- Z-1555-2009
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2008-04-28
- Posted
- not on file
- Terminated
- 2009-07-14
- Reason
- 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
- Root cause
- 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
- 4415 cartons
- Distribution
- Worldwide Distribution - including United States, United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal.
- Lot, serial or model codes
- Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).
- 510(k) numbers
- ["K051650"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28