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%.
“Randox Fructosamine Control 3 Recall: 25% Value Decrease in Calibration.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69396-randox-fructosamine-control-3-recall-25-value-decrease-in-calibration. Based on FDA recall #Z-1018-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1018-2019%22&limit=1).
The FDA announced on 2018-12-03 that Randox Laboratories Ltd. is recalling Fructosamine Control 3, FR2996, due to an incorrect assigned value for Fructosamine. The firm is conducting a device modification to reassign the value by a decrease of 25%. GovInfoNow's records show this voluntary Class II recall affects 133 kits distributed in CA, ME, MI, and WV.
How to tell if you have it
Brand: Randox
Product: Fructosamine Control 3, FR2996
Quantity: 133 kits
Distribution: US states CA, ME, MI, and WV
The hazard
The assigned value of Fructosamine in the calibrator and controls has been re-assigned by a decrease of 25%. The product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Other recent recalls include a 2024-06-07 Cystatin C Reagent recall for missing FDA 510(k) and a 2024-04-05 Evidence MultiSTAT Software v3.7 recall for light leak risk. Similar recent recalls of similar products include a 2026-03-16 Beckman Coulter Access Total T4 Calibrator recall, a 2025-12-11 Fujirebio Lumipulse pTau 217 Plasma Controls recall, and a 2026-05-07 Siemens Dimension Tacrolimus Flex Reagent Cartridge recall.
How to tell if you have this one
Check for the product name 'Fructosamine Control 3' with model number 500FR. This calibrator is used for in vitro calibration of Randox Liquid Fructosamine assays.
Brand
Randox
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Distribution to states to: CA, ME. MI, and WV.
Recall number
Product, codes & lots
Quantity
Z-1016-2019
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.; 498FR
85 kits
Z-1017-2019
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.; 499FR
141 kits
Z-1018-2019
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.; 500FR
133 kits
Based on the official FDA remedy
What to do — step by step
Check Calibration Value
Verify the calibrator's assigned value has been reduced by 25% compared to previous standards.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states to: CA, ME. MI, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Maine, Michigan, West Virginia.
Recall timeline
FDA published this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1018-2019 (December 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1018-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.