Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System
FDA device recall Z-1731-2009 · posted 2009-08-12 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- possibility of falsely elevated results
- Action taken
- Siemens Healthcare Diagnostics issued a letter to their customers starting April 8, 2008 informing them of the problem and to discontinue use of the product. Further questions should be addressed to Siemens Healthcare Diagnostics, Inc. at 1-800-441-9250.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 4,574 cartons
- Distribution
- Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia.
- Date initiated
- 2008-04-08
- Date posted
- 2009-08-12
- Date terminated
- 2009-08-13
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION CTNI FLEX REAGENT CARTRIDGE (K010313) | Dade Behring, Inc. | 2001-04-20 |