Recall Z-0858-2010 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk or mortality.
| Date | Feb 25, 2010 (initiated Mar 2, 2007) |
| Status | Terminated |
| Reason | Tests exhibit falsely elevated results. |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 9767 cartons |
| Distribution | Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010313 | DIMENSION CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc., Apr 20, 2001 |