Z-1732-2011

Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I...

Name: Z-1732-2011 Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-12-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-12-23 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the... on 2010-12-23. The reason FDA records is "Low frequency of non-repeatable falsely elevated CTNI results without an associated error message". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1732-2011
Status: Terminated
Initiated: 2010-12-23
Posted: 2011-03-18
Terminated: 2013-03-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an in vitro diagnostic test for the measurement of cardiac Troponin I in heparinized plasma. Cardiac Troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac Troponin I can also be used as an aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality.
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.
FDA root cause: Other
Action: The firm, SIEMENS, sent an "Urgent Field Safety Notice" letter dated December 2010 to all Stratus(R) CS Instrument customers. The letter described the product, problem and actions to be taken. The customers were instructed to repeat testing of samples with CTNI results above 0.07 ng/mL; discuss content of this letter with their laboratory director regarding the need to review test results reported from CTNI TestPak lots 230200002 or greater; complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to Technical Solutions Center at 302-631-8467, and forward this notification to anyone to whom they may have distributed this product. If you have any questions, please contact the Siemens Technical Solutions Center at 800-405-6473.
Quantity in commerce: 11635
Distribution: Worldwide distribution: AL, AK, AZ, AR, CA, CO, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.Product was distributed to foreign accounts in Algeria, Armenia, Australia, Austria, Bahrain, Bangladesh,Belgium, Bosnia & Herzegovina, Canada, Canary Islands, Czech Republic, Cyprus, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Guadeloupe, Indonesia, India, Israel, Ireland, Italy, Japan, Libya, Malaysia, Morocco, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Arab Emirates.
Product codes and lots: Lot #s: 230347002, 230340002, 230333002, 230326002, 230319002, 230312002, 230305002, 230298002, 230284002, 230277002, 230270002, 230263002, 230256002, 230250002, 230242002, 230236002, 230227002, 230214002, 230207002, 230201002 and 230200002.

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)