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Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of card
Recalled August 7, 2019 · FDA recall Z-2135-2019 · Siemens Healthcare Diagnostics
Hazard
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. · FDA Class II
Units
2312
Sold at
US Nationwide Distribution
Description
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
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(s)
Siemens Healthcare Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →