Randox recalls Calibration Serum Level 3 CAL2351 (lot numbers 1214UE-1315UE) due to potential 13% shift in test accuracy on RX Series instruments. Affected users should contact Randox for guidance.
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Randox is recalling Calibration Serum Level 3 CAL2351 because it may cause up to 13% shifts in test accuracy when used with RX Series instruments. This could lead to incorrect patient results if not addressed.
The calibration serum may cause test results to shift by up to 13% compared to other methods when used with RX Series instruments. This could lead to incorrect patient results if the shift is not corrected.
Users of Randox Calibration Serum Level 3 CAL2351 with RX Series instruments are affected. Laboratory staff and healthcare providers using this product are most at risk of inaccurate test results.
Check for lot numbers 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, or 1315UE on the product label. The product is sold under the brand Randox Laboratories Ltd.
Reach out to Randox Laboratories Ltd. for specific guidance on handling the recalled product.
The recall indicates a potential 13% shift in test accuracy, but it does not pose a direct safety risk like injury or fire. The hazard is related to test accuracy, not physical harm.
Contact Randox Laboratories Ltd. for specific guidance on handling the recalled product. There is no immediate need to stop using it.
Check the lot number on the product label. Recalled lots are 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, or 1315UE.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0752-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0752-2024 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.
