Siemens Healthcare Diagnostics, Inc.: 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.

Recall number

Z-1732-2011

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.

Status

Terminated

Initiated

2010-12-23

Posted

2011-03-18

Terminated

2013-03-19

Reason

Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.

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

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.

Lot, serial or model codes

Lot #s: 230347002, 230340002, 230333002, 230326002, 230319002, 230312002, 230305002, 230298002, 230284002, 230277002, 230270002, 230263002, 230256002, 230250002, 230242002, 230236002, 230227002, 230214002, 230207002, 230201002 and 230200002.

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

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

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