The Recall Desk
HighFDA (Devices)·Z-1673-2025·Announced 2025-05-07

Stratus CS Acute Care cTNI TestPak cardiac troponin test recall

Siemens Healthcare Diagnostics is recalling Stratus CS Acute Care cTNI TestPak, a cardiac troponin I test, due to an increased occurrence of false positive results during the product's shelf life.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The source identifies this as an FDA Class II recall. False positive cardiac troponin results pose a risk of patient harm through incorrect clinical decisions (unnecessary interventions or failure to treat actual cardiac events). No reported illnesses or injuries are stated in the source, but the hazard is inherent to the defect and applicable to high-risk patient populations.

Plain-English summary

Siemens Healthcare Diagnostics Inc. is recalling the Stratus CS Acute Care cTNI TestPak, an in vitro diagnostic (IVD) test for cardiac troponin I in heparinized plasma. The recall is being conducted by removal.

The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac troponin I (cTnI) results that can occur at any point during the TestPak's shelf life.

The affected product is Stratus CS Acute Care cTNI TestPak with Siemens Materials No. 10445071; UDI-DI: 0405686902174VK; and Lot No. 234337002 and forward. A total of 367 units were distributed worldwide, including in the U.S. states of California, Illinois, Kansas, Michigan, Missouri, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, and Wisconsin, as well as in Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland, and Vietnam.

Anyone who has received or used this product should contact Siemens Healthcare Diagnostics Inc. for further guidance on appropriate actions.

The recalled product

Product
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Manufacturer
Siemens Healthcare Diagnostics Inc
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • false-positive-result
  • diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Siemens Materials No. 10445071
  • UDI-DI: 0405686902174VK
  • Lot No. 234337002 and forward.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category