Randox recalls cholesterol test kits that may produce inaccurate results due to reduced linearity in calibration. Affected kits have specific catalog numbers and expiry dates. Consumers should contact Randox for guidance.
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
Randox is recalling cholesterol test kits that may give inaccurate results when used for quantitative cholesterol testing. This could lead to delayed results or incorrect health assessments if the kits are used without proper calibration.
The test kits may produce inaccurate cholesterol results because the calibration process shows reduced linearity, leading to lower absorbance changes than expected. This can cause quality control results to fall outside the expected range, potentially delaying accurate results.
People who purchased Randox cholesterol test kits with catalog number CH2O0 and expiry date January 28, 2024 are likely affected. Those using the kits for home cholesterol testing may experience delayed results if the kits are not calibrated correctly.
Check for catalog number CH2O0 and expiry date January 28, 2024 on the test kit packaging. The kits are sold by Randox Laboratories Ltd. for home cholesterol testing.
Look for catalog number CH2O0 and expiry date January 28, 2024 on the test kit packaging.
The test kits may produce inaccurate results due to reduced linearity in calibration, which can lead to delayed results.
The official recall notice does not specify a remedy or action steps for affected kits.
The recall states there is no risk of serious injury; the issue is with test accuracy, not physical safety.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1424-2022 — Randox Randox Hello, I own a Randox that is covered by recall Z-1424-2022 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.
