FDA recall Z-2135-2019

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).

Reason for recall

Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-05-29

Report date

2019-08-07

Termination date

2022-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2019