Randox recalls cholesterol test system (REF CH200) due to calibration errors causing high results. Affected lots from June 2022 to July 2023. No remedy stated in official notice.
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
Randox is recalling its cholesterol test system (REF CH200) because calibration errors can cause test results to be higher than expected. This could lead to inaccurate health assessments if used without proper calibration.
The test system may produce high results when calibrated with the kit's standard. This happens because the change in absorbance is lower than expected, causing internal quality control to show results outside the normal range.
People who use the Randox CHOL test system for cholesterol testing are affected. Those with recent test results from the recalled lots (559344 exp 28 June 2022 or 572730 exp 28 July 2023) are most at risk.
Check the lot number on the test system packaging. Affected lots are 559344 (expires 28 June 2022) or 572730 (expires 28 July 2023).
Look for lot numbers 559344 or 572730 on the test system packaging.
The official recall notice does not state any remedy or fix for this issue.
The official recall notice does not specify any action steps for affected users.
Check the lot number on the packaging. Affected lots are 559344 (expires 28 June 2022) or 572730 (expires 28 July 2023).
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0328-2022 — Randox Randox Hello, I own a Randox that is covered by recall Z-0328-2022 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.
