Z-1016-2019 Class II Ongoing
FDA device recall Z-1016-2019 was initiated by Randox Laboratories Ltd. on Dec 3, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 85 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 27, 2019
- Initiation Date
- Dec 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 kits
Product Description
Fructosamine Calibrator, FR2993 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
498FR
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1016-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026