Randox recalls Microalbumin Calibrator Series (mALB CAL) for potential misclassification of patient results due to negative bias in calibration. Affected units may show up to +12% shift in quality control and patient sample recovery.
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Randox is recalling its Microalbumin Calibrator Series (mALB CAL) because it may misclassify patient results. This could lead to inaccurate test results, potentially affecting patient care decisions.
The calibrators run with a negative bias compared to other methods, which may cause patient results to be misclassified. This could lead to shifts in quality control and patient sample recovery up to +12%.
Laboratories using Randox Microalbumin Calibrator Series (mALB CAL) for patient testing are affected. Users of these calibrators in clinical settings are most at risk of inaccurate test results.
Check for the product name 'Microalbumin Calibrator Series (mALB CAL)' with catalog number MA2426. Affected units have specific batch/lot numbers: 602114, 636645, or 662429.
Identify the catalog number and batch/lot numbers to confirm if your unit is affected.
The recalled product is the Microalbumin Calibrator Series (mALB CAL) with catalog number MA2426.
Check for the catalog number MA2426 and batch/lot numbers 602114, 636645, or 662429.
The recall record does not specify a remedy, so contact Randox Laboratories for further guidance.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1594-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-1594-2024 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.
