Siemens Stratus CS Acute Care cTNI TestPak Recalled for False Positives
Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPaks due to a potential for increased false positive results.
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 recall involves a high-risk diagnostic product where the hazard (false positives) could lead to misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc is recalling 2,312 units of the Stratus CS Acute Care cTNI TestPak (SMN 10445071). This in vitro diagnostic test is used to measure cardiac troponin I in heparinized plasma, which aids in the diagnosis of acute myocardial infarction (AMI).
The recall is being conducted because of a potential for an increased rate of false positive results and/or an increased rate of random non-repeatable false positive results. The affected units are identified by Lot # 238330002 forward, with expiration dates ranging from May 25, 2019, to November 2, 2019.
The product was distributed nationwide in the United States. Users of the affected test paks should stop using them and contact Siemens Healthcare Diagnostics Inc for further instructions.
The recalled product
- Product
- Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
- Manufacturer
- Siemens Healthcare Diagnostics Inc
- Hazard
- Affected units
- 2,312
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)
- Lot # 238330002 forward Expiration Dates - May 25
- 2019 - November 2
- 2019
Distribution
Distributed nationwide across the United States.
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