Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method Recalled by Siemens Healthcare Diagnostics, Inc. Due to Dimension Vista HCYS lot 13064MA shows erratic recovery...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Quantity: 302
Why Was This Recalled?
Dimension Vista HCYS lot 13064MA shows erratic recovery of QC and patient samples.
Where Was This Sold?
This product was distributed to 9 states: CO, IA, MD, NJ, NC, OH, VA, WI, DC
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report