Recall Z-2135-2019— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2135-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-29

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2019-05-29, terminated 2022-05-12. It names one FDA 510(k) clearance: K051650. 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: Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Terminated: 2022-05-12
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.·cleared 2005-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.