Recall Z-0668-2009 ยท JHX Fluorometric Method, Cpk Or Isoenzymes
Dade Behring, Inc.
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
| Date | Jan 28, 2009 (initiated Jun 23, 2008) |
| Status | Terminated |
| Reason | Incorrect result: Potential for false elevation of CTnI results |
| Root cause | Nonconforming Material/Component |
| Action | Siemens issued an Urgent Field Safety Notice dated 6/23/08 with instructions to immediately discontinue use and discard the affected lots. Customers were also instructed to contact Siemens Customer Service Center at 800-241-0420 to request replacement product at no charge. |
| Quantity | 5868 cartons |
| Distribution | Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India. |
| 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 |