Randox recalls Liquid Assayed Chemistry Control Premium Plus Level 3 (LAE4215) due to incorrect Caeruloplasmin values in instructions. Most labs use target values safely, but misreporting risks patient errors.
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Randox is recalling a specific chemistry control product because its instructions for use have incorrect values for Caeruloplasmin. This could lead to misreporting patient results, though most labs use the correct target values and the risk is mitigated.
The instructions for use contain incorrect one and two standard deviation values for Caeruloplasmin. This could lead to misreporting patient results if labs use the wrong values. However, most labs use the target and range values instead, which are correct.
Clinical labs that use this specific chemistry control product may be affected. Labs using the product for patient testing could face misreporting if they rely on the incorrect values.
Look for the product name 'Liquid Assayed Chemistry Control Premium Plus Level 3' with catalog number LAE4215. The lot number 1308UE is also associated with this recall.
Verify the catalog number LAE4215 and lot number 1308UE on the product label.
The recall is due to incorrect values in the instructions, but most labs use the correct target values, so patient risk is low.
No, labs typically use the target values safely; the recall does not require immediate discontinuation.
Check the catalog number and lot number on the product label to confirm if it's affected.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2609-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-2609-2023 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.
