Recall Z-1732-2011 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Troponin I method (CTNI) is an 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). Cardiac Troponin I can also be used as an aid in the risk stratification of
| Date | Mar 18, 2011 (initiated Dec 23, 2010) |
| Status | Terminated |
| Reason | Low frequency of non-repeatable falsely elevated CTNI results without an associated error message. |
| Root cause | Other |
| Action | The firm, SIEMENS, sent an "Urgent Field Safety Notice" letter dated December 2010 to all Stratus(R) CS Instrument customers. The letter described the product, problem and actions to be taken. The customers were instructed to repeat testing of samples with CTNI results above 0.07 ng/mL; discuss content of this letter with their laboratory director regarding the need to review test results reported from CTNI TestPak lots 230200002 or greater; complete and return the FIELD CORRECTION EFFECTIVENESS CHECK form via fax to Technical Solutions Center at 302-631-8467, and forward this notification t |
| Quantity | 11635 |
| Distribution | Worldwide distribution: AL, AK, AZ, AR, CA, CO, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.Product was distributed to foreign accounts in Algeria, Armenia, Australia, Austria, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. Dade Behring, Inc., Sep 8, 2005 |