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).
Reported: August 7, 2019 Initiated: May 29, 2019 #Z-2135-2019
Product Description
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).
Reason for Recall
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 2312
- Distribution
- US Nationwide Distribution
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 2312.
Why was this product recalled? ▼
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2135-2019.
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