Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
FDA device recall Z-0668-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Dade Behring, Inc.
- Reason for recall
- Incorrect result: Potential for false elevation of CTnI results
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JHX
- Quantity affected
- 5868 cartons
- Distribution
- Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
- Date initiated
- 2008-06-23
- Date posted
- 2009-01-28
- Date terminated
- 2009-01-29
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650) | Dade Behring, Inc. | 2005-09-08 |