Device 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.
Z-1017-2019
Product summary
- Event
- Event 81783
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 141 kits
- Official record key
device-enforcement:Z-1017-2019
Official wording
Reason: 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%.
Code information: 499FR
Distribution pattern: US Distribution to states to: CA, ME. MI, and WV.
Derived failure modes
-
Unknown
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%.