Siemens Healthcare Diagnostics, Inc. Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D), Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS), Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.
Products Sold
Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.
Siemens Healthcare Diagnostics, Inc. is recalling Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in se due to . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, FL, IN, MN, MT, NY
Page updated: Jan 10, 2026