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%.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Randox Laboratories Ltd.
See all →- ModerateCystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
FDA (Devices) · 2024-07-31
- HighRandox Clinical Chemistry Calibration Serum Recalled for Measurement Bias
FDA (Devices) · 2024-05-15
- ModerateEvidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
FDA (Devices) · 2024-05-15
- HighMicroalbumin Calibrator Series Recalled for Negative Bias and Patient Result Misclassification
FDA (Devices) · 2024-04-24
- HighMicroalbumin Calibrator Series Recall Due to Measurement Accuracy Issue
FDA (Devices) · 2024-04-24
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighFDA Recalls Randox Liquid Protein Calibrators for Measurement Accuracy Error
FDA (Devices) · 2023-08-30
- ModerateRandox Liquid Protein Calibrators Recalled for Rheumatoid Factor Value Adjustment
FDA (Devices) · 2019-11-13
- ModerateRandox Blood Gas Control Level 2 Recalled for pH Range Error
FDA (Devices) · 2019-04-03
- ModerateRandox SP CAL (LIQ) Calibrator Recall for Value Sheet Corrections
FDA (Devices) · 2019-01-02
- ModerateRandox Liquid Cardiac Control Level 3 Recalled for Precision Issues
FDA (Devices) · 2018-08-08
- ModerateRandox CK MB Calibrator recalled due to calibration inaccuracy affecting test results
FDA (Devices) · 2022-05-25