FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
- Recall number
- Z-1673-2025
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
- Status
- Open, Classified
- Initiated
- 2025-03-31
- Posted
- 2025-04-25
- Terminated
- not on file
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; Lot No. 234337002 and forward.
- 510(k) numbers
- ["K051650"]
- PMA numbers
- not on file
- Product code
- JHX
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28