Randox recalls SP CAL (LIQ) REF IT2692 due to calibrator value sheet updates for Alpha-1-Acid-Glycoprotein and IgG tests. This affects in vitro diagnostic use with specific assays.
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
Randox is recalling SP CAL (LIQ) REF IT2692, a calibrator for diagnostic tests. The recall is due to updated value sheets for Alpha-1-Acid-Glycoprotein and IgG measurements, which may affect test accuracy if not adjusted properly.
The calibrator value sheets were modified to improve alignment with Alpha-1-Acid-Glycoprotein (AGP), IgA, and IgG measurements. This update corrects the IgG reference value but may require adjustments to ensure accurate test results if not properly followed.
Users of Randox SP CAL (LIQ) REF IT2692 for in vitro diagnostic tests with Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG, and IgM assays are affected. Laboratory staff and healthcare providers using this calibrator are most at risk.
Check for the product name SP CAL (LIQ) with reference number IT2692. This calibrator is used with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG, and IgM assays that require sample predilution.
Verify the product name and reference number on the calibrator label.
The calibrator value sheets were updated to improve alignment with Alpha-1-Acid-Glycoprotein and IgG measurements, which requires specific adjustments for accurate test results.
No, this recall is for calibration updates, not a safety hazard. Users should check the product details and follow the updated instructions.
Check the product label for the reference number IT2692 and ensure you follow the updated calibration instructions for accurate test results.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0660-2019 — Randox Randox Hello, I own a Randox that is covered by recall Z-0660-2019 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.
