Randox recalls Microalbumin Calibrator Series (mAL:CAL) MA1567 and MA2426 due to potential misclassification of patient results. Users may see up to +12% shifts in quality control and sample recovery.
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and 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) models MA1567 and MA2426 because they may misclassify patient results by up to 12%. This could lead to inaccurate health assessments if used in medical testing.
The calibrators run with a negative bias compared to other methods, causing patient results to be misclassified. This can shift quality control and sample recovery by up to 12%, potentially leading to inaccurate health assessments.
Healthcare professionals using the Microalbumin Calibrator Series for medical testing are affected. Patients relying on these calibrators for accurate results may be at risk of incorrect health assessments.
Check for the product name 'Microalbumin Calibrator Series (mALB CAL)' with catalog numbers MA1567 or MA2426. The batch numbers are 619282 or 1094MA-1098MA.
Identify the catalog number (MA1567 or MA2426) and batch number (619282 or 1094MA-1098MA) on the product label.
The Microalbumin Calibrator Series may misclassify patient results by up to 12% due to a negative bias compared to other methods.
Using the recalled calibrators could lead to inaccurate patient results, potentially affecting health assessments.
Look for catalog numbers MA1567 or MA2426 with batch numbers 619282 or 1094MA-1098MA on the product label.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1593-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-1593-2024 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.
