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.
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 TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.
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.
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.
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.
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.
Discontinue use of the Stratus CS Acute Care cTNI TestPak if you have it.
The recall is due to an increased occurrence of random non-repeatable false positive cardiac troponin I results at any point during the test's shelf life.
Stop using it immediately to avoid inaccurate heart test results. Contact Siemens Healthcare for a replacement.
Check for Siemens Materials No. 10445071, lot numbers starting with 234337002, and UDI-DI code 0405686902174VK.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1673-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1673-2025 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
