Randox recalls Fructos:amine Calibrator FR2993 due to 25% decrease in assigned value. This affects calibration accuracy for clinical chemistry systems. Affected units may require re-calibration.
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 its Fructosamine Calibrator (FR2993) because the assigned value for fructosamine has been reduced by 25%. This could lead to inaccurate calibration results in clinical chemistry systems, potentially affecting patient testing.
The calibrator's assigned fructosamine value has been decreased by 25% compared to the intended standard. This could cause calibration errors in clinical chemistry systems, leading to inaccurate patient test results.
Healthcare professionals using the Fructosamine Calibrator for clinical chemistry testing are most affected. Patients relying on accurate test results may be impacted indirectly.
Check for the product name 'Fructosamine Calibrator, FR2993' on the device. This product is used for in vitro calibration of Randox Liquid Fructosamine assays.
Verify the calibrator's assigned value has been updated by 25% to ensure accurate calibration results.
The assigned value of fructosamine in this calibrator has been decreased by 25%, which could lead to inaccurate calibration results.
Inaccurate calibration could affect patient test results, but the recall does not indicate immediate health risks.
Look for the product name 'Fructosamine Calibrator, FR2993' used for in vitro calibration of Randox Liquid Fructosamine assays.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1016-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-1016-2019 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.
