Dimension Flex Reagent Cartridge Cardiac Tropinin-I… recallZ-0858-2010 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 2, 2007
Terminated All recalls posted in February 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Tests exhibit falsely elevated results.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-0858-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 2, 2007
- Posted by the FDA
- Feb 25, 2010
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 9767 cartons
- Product code
- MMI
- FDA submissions
- K010313
- Distribution
- Worldwide Distribution -- USA, Canada, Germany, Egypt, New Zealand, Saudi Arabia, Singapore, and BS.
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers: GF7353 exp 12/19/07, FF7362 exp 12/28/07, and GE7353 exp 12/19/07.
Other devices under the same FDA submission
2 devices cleared under K010313 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension Cardiac Troponin-I Flex reagent cartridge 10444896Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall8 reports
- Dimension Cardiac Troponin-I Flex reagent cartridge 10444905Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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