Randox Fructosamine Calibrator Recall Due to Value Reassignment
Randox Laboratories is recalling 141 kits of Fructosamine Control 1 because the assigned value was decreased by 25%.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 voluntary precautionary measure to correct a calibration value, with no reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Randox Laboratories Ltd. is conducting a device modification for Fructosamine Calibrator, Fructosamine Control 1, and Control 3. The recall involves 141 kits of Fructosamine Control 1 (code 499FR) distributed to California, Maine, Michigan, and West Virginia.
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.
No specific instructions for consumers are provided in the source text, but the recall is limited to the specified lots and distribution areas.
The recalled product
- 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.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 141
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)
- 499FR
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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