Z-1673-2025Class II

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

Name: Z-1673-2025 Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma
Creator: Siemens Healthcare Diagnostics Inc
Published: 2025-03-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-03-31 / Open, Classified

FDA source

Siemens Healthcare Diagnostics Inc began a recall of Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma on 2025-03-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1673-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-31
Posted: 2025-04-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Product code: JHX Fluorometric Method, Cpk Or Isoenzymes
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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 Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & Vietnam.
Product codes and lots: Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; Lot No. 234337002 and forward.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1673-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1673-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-07	2025-04-25

Product code JHX

K051650Class IIStratus Cs Acute Care Mb Isoenzyme of Creatine Kinase (Ckmb) Test Pak; Stratus Cs Acute Care Ckmb Testpak.Dade Behring, Inc. / cleared 2005-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)