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

FDA device recall Z-1673-2025 · posted 2025-04-25 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JHX

Quantity affected

367 units

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 Macedoni

Date initiated

2025-03-31

Date posted

2025-04-25

Location

Norwood, MA

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