Randox Laboratories Ltd.: 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%.

Agency Publication Date: March 15, 2019

Affected Products

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.

498FR

Product: 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.

499FR

Product: Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

500FR

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81783

Status: Active

Manufacturer: Randox Laboratories Ltd.

Manufactured In: Ireland

Units Affected: 3 products (85 kits; 141 kits; 133 kits)

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Sources: FDA iRES · Raw API Response

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