medical Class II Updated 2019-03-27

Randox Laboratories Ltd. recalls Fructosamine Calibrator, FR2993 This product is intended

Recalled 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.

Hazard / Issue

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%.

Issued by

FDA

Affected States: CA, ME, MI, WV
Lot/Code Info: 498FR
View official government recall

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