Z-1555-2009

Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the...

Name: Z-1555-2009 Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2008-04-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-04-28 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2008-04-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1555-2009
Status: Terminated
Initiated: 2008-04-28
Posted: 2015-06-25
Terminated: 2009-07-14
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.
Product code: MMI Immunoassay Method, Troponin Subunit
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
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008).

Product code MMI

K051650Class IIStratus Cs Acute Care Mb Isoenzyme of Creatine Kinase (Ckmb) Test Pak; Stratus Cs Acute Care Ckmb Testpak.Dade Behring, Inc. / cleared 2005-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)