Device 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).
Z-2135-2019
Product summary
- Event
- Event 82990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2312
- Official record key
device-enforcement:Z-2135-2019
Official wording
Reason: Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.
Code information: Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.