Randox recalls Calibration Serum Level 3 (CAL 3) and Human Assayed Multi-Sera Level 2 (HN1530) due to transcription errors in instructions for bilirubin, triglycerides, and TBIC target values. Affected lots expire by November 2024 to May 2025.
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
Randox is recalling specific calibration serum products because their instructions for use contain transcription errors for bilirubin, triglycerides, and TBIC target values. This could lead to incorrect test results if users follow the flawed instructions.
The instructions for use (IFU) for specific calibration serums contain transcription errors in target values for bilirubin, triglycerides, and TBIC. This means users might interpret the instructions incorrectly, leading to inaccurate test results if they follow the flawed guidance.
Laboratory users who have the affected calibration serums (lots 1260UE, 1262UE, or 1315UE) may be at risk of inaccurate test results. The risk is low as the error is in the instructions, not the product itself.
Check for the product names: Calibration Serum Level 3 (CAL 3, REF CAL2351) or Human Assayed Multi-Sera Level 2 (HN1530). The affected lots are 1260UE (expires Nov 2024), 1262UE (expires Jan 2025), and 1315UE (expires May 2025).
Look for lot numbers 1260UE, 1262UE, or 1315UE on the product packaging.
The instructions for use (IFU) contain transcription errors for bilirubin, triglycerides, and TBIC target values in the affected calibration serums.
No, the recall is for the instructions, not the product itself. Users can continue using the products but should follow the corrected instructions from Randox.
Lot 1260UE expires November 28, 2024; lot 1262UE expires January 28, 2025; and lot 1315UE expires May 28, 2025.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0751-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0751-2024 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.
