Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
FDA device recall Z-2400-2010 · posted 2010-09-11 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- False elevated Stratus CS CTNI results
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 7500 cartons
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-04-13
- Date posted
- 2010-09-11
- Date terminated
- 2010-10-25
- 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 |