Randox recalls Fructos:amine Control 1 (FR2994) due to a 25% decrease in assigned fructosamine value affecting calibration accuracy. Affected units may need recalibration.
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 1 (FR2994) because the assigned fructosamine value has been reduced by 25%. This could lead to inaccurate calibration of clinical chemistry systems, potentially affecting test results.
The calibrator's fructosamine value has been decreased by 25% compared to the intended standard. This change could cause calibration errors in clinical chemistry systems, leading to inaccurate test results.
Healthcare professionals using the Fructosamine Control 1 for calibration in clinical labs are most at risk. The recall affects specific lots of this product.
Check for the product name 'Fructosamine Control 1' with lot number FR2994. This product is used for calibrating clinical chemistry systems.
Verify if your clinical chemistry system requires recalibration after using the affected calibrator.
The assigned fructosamine value in the calibrator has been decreased by 25%, which could lead to inaccurate calibration of clinical chemistry systems.
Check if your clinical chemistry system requires recalibration after using the affected calibrator.
No, this is a calibration issue that does not pose a physical safety risk.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1017-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-1017-2019 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.
