Siemens Stratus CS cTNI TestPak Recall: False Positive Cardiac Troponin Risk
Siemens Healthcare recalls Stratus CS Acute Care cTNI TestPak for increased false positive cardiac troponin I results. Affected units have specific lot numbers and serial codes. Stop using immediately to avoid inaccurate heart test results.
Use caution until it’s fixed
Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPak s shelf life when using the Stratus CS cTnI Acute Care Testpak.
Contact the company
What happened, in plain English
Siemens Healthcare is recalling Stratus CS Acute Care cTNI TestPaks due to a higher chance of false positive cardiac troponin I results. This could lead to incorrect heart condition diagnoses if used without the recall fix. Read more at govinfonow.com/recall/52514-siemens-stratus-cs-ctni-testpak-recall-false-positive-cardiac-troponin.
Source Summary by GovInfoNow · govinfonow.com/recall/52514-siemens-stratus-cs-ctni-testpak-recall-false-positive-cardiac-troponin · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1673-2025
Cite this page
“Siemens Stratus CS cTNI TestPak Recall: False Positive Cardiac Troponin Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52514-siemens-stratus-cs-ctni-testpak-recall-false-positive-cardiac-troponin. Based on FDA recall #Z-1673-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1673-2025%22&limit=1).
Why it’s dangerous
The test can produce random false positive results for cardiac troponin I at any time during its shelf life. This means the test might incorrectly indicate a heart problem when there isn't one, leading to unnecessary medical concerns.
Who’s affected
Healthcare providers using the Stratus CS cTNI TestPak for cardiac troponin I testing are most at risk. Patients receiving these tests may get inaccurate results if the test is used without correction.
How to tell if you have this one
Check for the Siemens Materials No. 10445071 on the test kit. Look for lot numbers starting with 234337002 and later. The UDI-DI code 0405686902174VK is also unique to this recall.
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Stop Using Immediately
Discontinue use of the Stratus CS Acute Care cTNI TestPak if you have it.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Illinois, Kansas, Michigan, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Wisconsin.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1673-2025 (March 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1673-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.