Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Intended to quantitatively measur
FDA device recall Z-0858-2010 · posted 2010-02-25 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Tests exhibit falsely elevated results.
- Action taken
- The recalling firm issued a Field Correction letter dated 3/2/07 informing user of the problem and to contact the firm at 800-241-0420 for replacements. Customers are to follow the precautions provided in the letter. Questions should be directed to Dade Behring Technical Assistance Center at 800-441-9250. The notification should be forwarded to anyone to whom the product may have been further distributed to.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MMI
- Quantity affected
- 9767 cartons
- Distribution
- Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS.
- Date initiated
- 2007-03-02
- Date posted
- 2010-02-25
- Date terminated
- 2010-02-25
- 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 |