Randox recalls specific batches of liquid protein calibrators due to potential 10% higher ferritin results. Affected batches include 627222, 627224, 634886, and 634887. No action is required for users.
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference material NISBC 19/118. The calibrators lots 2112IT-2116IT, packed into batches 627222, 627224, 634886 and 634887 have been reassigned as part of the restandardization. Following this restandardization, Ferritin results for Quality Control material and patient samples recovered erroneously higher than the targeted calibrator values by approximately +10% across the assay range following.
Randox is recalling specific batches of liquid protein calibrators that may cause ferritin test results to be 10% higher than expected. This could lead to inaccurate medical diagnoses if used in patient testing. The recall does not require immediate action for users.
The recalibrated calibrators may produce ferritin results that are 10% higher than intended. This could cause inaccurate test results for certain blood tests, potentially affecting medical diagnoses. However, the issue does not pose a direct safety risk to users.
Users of Randox Liquid Protein Calibrators-SP CAL-(LIQ) for medical testing are affected. Laboratories using the recalled batches (627222, 627224, 634886, 634887) are most at risk.
Check for batch numbers 627222, 627224, 634886, or 634887 on the calibrator packaging. The product is used for calibrating blood tests for ferritin and other markers.
Look for batch numbers 627222, 627224, 634886, or 634887 on the calibrator packaging.
Randox recalibrated the ferritin in these calibrators, causing results to be 10% higher than expected. This was identified during internal quality monitoring.
No action is required. The recall does not affect the safety of the product but may impact test accuracy.
Batches 627222, 627224, 634886, and 634887 are affected.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2448-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-2448-2023 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.
