Randox recalls NEFA CAL IVD standard (FA115) due to incorrect calibration causing up to +8% false high results in patient tests. Affected batches expire Nov 2022.
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
Randox is recalling its NEFA CAL IVD standard (catalog FA115) because it was calibrated incorrectly. This can cause test results to be up to 8% higher than actual values, potentially leading to misdiagnosis of fatty acid levels.
The standard was assigned incorrectly during packaging, causing calibration values to be too high. When used in tests, this shifts results by up to 8% higher than true values, which could lead to misdiagnosis of conditions like metabolic disorders.
Lab technicians and healthcare providers using the NEFA CAL standard for blood tests. Those who rely on accurate fatty acid measurements for patient diagnosis are most at risk.
Check for catalog number FA115, batch number 544642, and expiration date of November 28, 2022. This product was sold as an IVD standard for measuring non-esterified fatty acids.
Check the catalog number (FA115), batch number (544642), and expiration date (November 28, 2022) on the product label.
The NEFA CAL standard was assigned incorrectly during packaging, causing calibration values to be too high. This can shift test results by up to 8% higher than actual values.
Using this standard may cause test results for non-esterified fatty acids to be up to 8% higher than true values, potentially leading to misdiagnosis.
Look for catalog number FA115, batch number 544642, and expiration date of November 28, 2022 on the product label.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-2099-2021 — Randox Randox Hello, I own a Randox that is covered by recall Z-2099-2021 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.
