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.
Hazard
Tests exhibit falsely elevated results.
What You Should Do
Remedy
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.
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Products
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
- Brand
- Siemens Healthcare Diagnostics, Inc.
- UPC
- Lot numbers: GF7353 exp 12/19/07, FF7362 exp 12/28/07, and GE7353 exp 12/19/07.
Units Affected
9767 cartons