Randox Laboratories Ltd. recalls Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructo…

Recall date

December 3, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1017-2019

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US Distribution to states to: CA, ME. MI, and WV.

Why it was 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%.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.