FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0858-2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2007-03-02
- Posted
- 2010-02-25
- Terminated
- 2010-02-25
- 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.
- Lot, serial or model codes
- Lot numbers: GF7353 exp 12/19/07, FF7362 exp 12/28/07, and GE7353 exp 12/19/07.
- 510(k) numbers
- ["K010313"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28