Randox recalls Fructos: 25% value decrease in calibration controls may affect test accuracy. Affected units: 500FR model for in vitro use.
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 is recalling Fructosamine Control 3 (FR2996) because its calibration value has been reduced by 25%. This could lead to inaccurate test results if used in clinical chemistry systems.
The calibrator's assigned value has been decreased by 25% compared to previous standards. This change could cause test results to be inaccurate, potentially affecting patient care if used without adjustment.
Healthcare professionals using the Fructosamine Control 3 for in vitro calibration in clinical chemistry systems. Those who have the 500FR model are most at risk.
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.
Verify the calibrator's assigned value has been reduced by 25% compared to previous standards.
The assigned value of Fructosamine in this calibrator has been decreased by 25% compared to previous standards, which could lead to inaccurate test results.
The recall record does not specify a remedy or action steps for affected users.
The recall record indicates a potential for inaccurate test results due to the 25% value decrease, but does not state it is unsafe.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1018-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-1018-2019 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
