STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE - Stratus Cs Acute Care Mb Isoenzyme Of Creatine Kinase (Ckmb) Test Pak

• • Ongoing Z-1673-2025 FDA Class II ·initiated 31 Mar 2025

  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.

• • Terminated Z-2135-2019 FDA Class II ·initiated 29 May 2019 ·on shared 510(k) K051650

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

• 5 recalls, same reason

  • Terminated Z-0612-2016 FDA Class II ·initiated 11 Nov 2015 ·on shared 510(k) K051650
  • Terminated Z-0609-2016 FDA Class II ·initiated 11 Nov 2015 ·on shared 510(k) K051650
  • Terminated Z-0618-2016 FDA Class II ·initiated 11 Nov 2015 ·on shared 510(k) K051650
  • Terminated Z-0613-2016 FDA Class II ·initiated 11 Nov 2015
  • Terminated Z-0619-2016 FDA Class II ·initiated 11 Nov 2015

  Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems

• • Terminated Z-1732-2011 FDA Unclassified (pre-2012) ·initiated 23 Dec 2010 ·on shared 510(k) K051650

  Low frequency of non-repeatable falsely elevated CTNI results without an associated error message.

• • Terminated Z-2400-2010 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010 ·on shared 510(k) K051650

  False elevated Stratus CS CTNI results

• • Terminated Z-0668-2009 FDA Unclassified (pre-2012) ·initiated 23 Jun 2008

  Incorrect result: Potential for false elevation of CTnI results

• • Terminated Z-1555-2009 FDA Unclassified (pre-2012) ·initiated 28 Apr 2008 ·on shared 510(k) K051650

  The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K051650 ↗

FDA Product Code

JHX

Models / Variants

Stratus Cs Acute Care Mb Isoenzyme Of Creatine Kinase (Ckmb) Test Pak

Stratus Cs Acute Care Ckmb Testpak.

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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