FDA-Device2019-03-27Class II
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.
Randox Laboratories Ltd.
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%.
Sold states
US Distribution to states to: CA, ME. MI, and WV.
Affected count
141 kits
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1017-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief