Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT Recalled by Axis-Shield Diagnostics, Ltd. Due to Deterioration in performance of the Liquid Stable (LS)...
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 Axis-Shield Diagnostics, Ltd. directly.
Affected Products
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.
Quantity: 52 kits + 75 kits Beckman Coulter Brand OUS
Why Was This Recalled?
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Axis-Shield Diagnostics, Ltd.
Axis-Shield Diagnostics, Ltd. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report