Randox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment
Randox Laboratories is recalling 133 kits of Fructosamine Control 3 because the assigned value was decreased by 25%. The product is used for in vitro calibration.
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 device modification to correct a calibration value, with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Randox Laboratories Ltd. is conducting a device modification for Fructosamine Control 3, lot code 500FR. The recall involves 133 kits distributed to California, Maine, Michigan, and West Virginia. This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
The recall is being conducted because the assigned value of Fructosamine in the calibrator has been re-assigned by a decrease of 25%. This modification affects the accuracy of the calibration process for the specific assay.
Healthcare facilities and laboratories that have received this product should stop using the affected lots and contact Randox Laboratories for further instructions. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- 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.
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 133
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)
- 500FR
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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