Randox recalls C3 and Haptoglobin liquid protein calibrators (IT2691) used with IgA/IgG/IgM assays due to realignment to ERM-DA470k/IFCC reference material. No immediate safety risk reported.
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Randox is recalling specific liquid protein calibrators (IT2691) used with their IgA, IgG, and IgM assays because they've been realigned to a new reference material. This change doesn't pose a safety risk to users but requires updating calibration procedures.
The calibrators have been realigned to a new reference material (ERM-DA470k/IFCC) which may cause inaccurate test results if not properly updated. This is a technical calibration change, not a safety hazard.
Users of Randox IgA, IgG, and IgM assays who use the IT2691 calibrators. Laboratory staff handling these specific calibrators are most at risk of incorrect results.
Check for the catalog number IT2691 on the calibrator packaging. These products were sold with batch numbers ending in 2154IT-2158IT (expiring 03/28/25) or 2112IT-2116IT (expiring 07/28/24).
Verify if your calibrator uses the IT2691 catalog number and matches the batch numbers listed in the recall notice.
No safety risk is reported; this is a technical calibration update that may affect test accuracy.
Check if your calibrator is IT2691 with the batch numbers listed in the recall notice. No action is needed if it's not affected.
Yes, the calibrators were sold with batch numbers ending in 2154IT-2158IT (expiring 03/28/25) or 2112IT-2116IT (expiring 07/28/24).
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1328-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-1328-2024 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.
