Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fructosamine Control 1 Recalled by Randox Laboratories Ltd. Due to The firm is conducting a Device Modification for...
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 Randox Laboratories Ltd. directly.
Affected Products
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Quantity: 141 kits
Why Was This Recalled?
The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.
Where Was This Sold?
This product was distributed to 4 states: CA, ME, MI, WV
About Randox Laboratories Ltd.
Randox Laboratories Ltd. has 72 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report