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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 367
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
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