FDA recall Z-1673-2025

Product

Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

Reason for recall

Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma by removal. The reason for the recall is an increased occurrence of random non-repeatable false positive cardiac Troponin l(cTnI) results at any point during the TestPaks shelf life when using the Stratus CS cTnI Acute Care Testpak.

Distribution

Worldwide - US Nationwide distribution in the states of CA, IL, KS, MI, MO, NJ, NY, OH, OK, PA, SC & WI. The countries of Austria, Canada, Chile, France, Germany, Iraq, Italy, Malaysia, North Macedonia, Saudi Arabia, Serbia, Slovenia, Spain, Sweden, Switzerland & Vietnam.

Key facts

Status

Ongoing

Initiation date

2025-03-31

Report date

2025-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwood, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2025