Recall Z-2400-2010 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
| Date | Sep 11, 2010 (initiated Apr 13, 2010) |
| Status | Terminated |
| Reason | False elevated Stratus CS CTNI results |
| Root cause | Process control |
| Action | Recalling firm issued " Urgent Field Safety Notice" dated April 2010, informing users of the problem and to discuss with laboratory directors regarding the need to review previous test results, conduct patient follow up, and/or repeat testing for tests conducted on or after Nov 1, 2009. |
| Quantity | 7500 cartons |
| Distribution | Nationwide Distribution |
| 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 |