Randox Fructosamine Calibrator Recall Due to Value Reassignment
Randox Laboratories is recalling 85 kits of Fructosamine Calibrator FR2993 because the assigned value was decreased by 25%.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a Class II device modification involving a calibration value change without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary action.
Plain-English summary
Randox Laboratories Ltd. is conducting a device modification for Fructosamine Calibrator FR2993, Fructosamine Control 1, and Control 3. The recall involves 85 kits distributed to California, Maine, Michigan, and West Virginia. The specific lot code is 498FR.
The recall is being conducted because the assigned value of Fructosamine in the calibrator and controls has been re-assigned by a decrease of 25%. This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the product.
The recalled product
- Product
- Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 85
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 498FR
Distribution
Part of a larger recall action
This product is one of 3 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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