Z-0668-2009

Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic

Name: Z-0668-2009 Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic
Creator: Dade Behring, Inc.
Published: 2008-06-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2008-06-23 / Terminated / root cause: manufacturing process

FDA source

Dade Behring, Inc. began a recall of Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic on 2008-06-23. The reason FDA records is "Incorrect result: Potential for false elevation of 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-0668-2009
Status: Terminated
Initiated: 2008-06-23
Posted: 2009-01-28
Terminated: 2009-01-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
Reason for recall: Incorrect result: Potential for false elevation of CTnI results
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge.
Quantity in commerce: 5868 cartons
Distribution: Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
Product codes and lots: Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.

Product code JHX

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)