Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Reported: March 27, 2019 Initiated: December 3, 2018 #Z-1018-2019
Product Description
Fructosamine Control 3, FR2996 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%.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 133 kits
- Distribution
- US Distribution to states to: CA, ME. MI, and WV.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.. Recalled by Randox Laboratories Ltd.. Units affected: 133 kits.
Why was this product recalled? ▼
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%.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 27, 2019. Severity: Moderate. Recall number: Z-1018-2019.
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