Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

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.

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

An Urgent Medical Device Correction notice dated March 2025 was mailed to consignees. The notice instructed consignees to review the provided notification with their medical director to determine the appropriate course of action. Siemens will reimburse users for repeat tests and discarded units associated with this recall; consignees should contact the Customer Care Center for reimbursement. If product was further distributed, Siemens asks that the recall notification be forwarded. The recall notification is to be retained with laboratory records and forwarded to those who use the recalled devices. Consignees with any questions can contact Siemens Healthineers Technical Solutions Center at 977-229-3711.

• FDA enforcement recordOfficial FDA database entry for Z-1673-2025
• FDA 510(k) clearance · K051650The device's official FDA premarket clearance record
• FDA device classification · JHXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1215The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.