Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS) Recalled by CSL Behring GmbH Due to Reagent lots # 15243MA and 15243MB shows a...
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 CSL Behring GmbH directly.
Affected Products
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
Quantity: 898 units
Why Was This Recalled?
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
Where Was This Sold?
This product was distributed to 36 states: AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, LA, MD, MA, MI, MS, MO, MT, NE, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, UT, VA, WV, WI, DC
About CSL Behring GmbH
CSL Behring GmbH has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report