Z-2400-2010

Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)

Name: Z-2400-2010 Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-04-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-04-13 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) on 2010-04-13. The reason FDA records is "False elevated Stratus CS CTNI results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2400-2010
Status: Terminated
Initiated: 2010-04-13
Posted: 2010-09-11
Terminated: 2010-10-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: False elevated Stratus CS CTNI results
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Recalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009.
Quantity in commerce: 7500 cartons
Distribution: Nationwide Distribution
Product codes and lots: lot# 239229002, EXP# 2/13/2010 lot# 239236002, EXP2/20/2010 lot# 239243002, EXP# 2/7/2010 lot# 239257002, EXP# 3/10/2010 lot# 239264002, EXP# 3/20/2010 lot# 239271002, EXP# 3/27/2010 lot# 239278002, EXP# 4/3/2010 lot# 239285002, EXP# 4/10/2010 lot# 239292002, EXP# 4/17/2010 lot# 239299002, EXP# 4/24/2010 lot# 239313002, EXP 5/8/2010 lot# 239334002, EXP 5/29/2010 lot# 239341002, EXP#6/5/2010 lot# 239362002, EXP# 6/26/2010

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)