Z-1017-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- December 3, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 kits
Product Description
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.
Reason for Recall
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%.
Distribution Pattern
US Distribution to states to: CA, ME. MI, and WV.
Code Information
499FR