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 There is a potential performance issue as detected...
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, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
Quantity: 740 total
Why Was This Recalled?
There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
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