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.
FDA Recall Z-0858-2010 · Posted 2010-02-25
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeMMI
Date Initiated2007-03-02
Date Terminated2010-02-25
Product Quantity9767 cartons
Reason for Recall
Tests exhibit falsely elevated results.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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