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Randox Laboratories Ltd. recalls Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fru
Recalled March 27, 2019 · FDA recall Z-1016-2019 · Randox Laboratories
Hazard
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%. · FDA Class II
Units
85 kits
Sold at
US Distribution to states to: CA, ME. MI, and WV.
Description
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%.
Product
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →