Lower riskMedical device recall · FDA · Published May 10, 2021
Randox NEFA CAL IVD Standard Recall: Incorrect Calibration Causes False High Results
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 NEFA CAL IVD Standard Recall: Incorrect Calibration Causes False High Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62584-randox-nefa-cal-ivd-standard-recall-incorrect-calibration-causes-false. Based on FDA recall #Z-2099-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2021%22&limit=1).
The FDA announced on May 10, 2021, that Randox Laboratories Ltd. recalled NEFA CAL IVD Standard (Catalog Number FA115) due to incorrect calibration values. The agency said the error can cause a positive shift of up to +8% in quality controls and patient samples.
How to tell if you have it
Brand: Randox
Product: NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA
Catalog Number: FA115
UPC: 05055273203066
Batch Number: 544642
Expiration Date: 28th Nov 2022
Distribution: US Nationwide in AR, CA, CT, NY, OH, PA, TN, and TX
The hazard
The FDA said the standard packed within the NEFA kit has been assigned an incorrect value. Calibrating with this incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Other recent recalls include the Randox Cystatin C Reagent Recall (June 7, 2024), the Randox Evidence MultiSTAT Software v3.7 Recall (April 5, 2024), and the Randox Clinical Chemistry Calibration Serum Recall (March 5, 2024). Other recent recalls of similar products include the Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), and the Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (December 11, 2025).
How to tell if you have this one
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.
Brand
Randox
Product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Product Details
Check the catalog number (FA115), batch number (544642), and expiration date (November 28, 2022) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Connecticut, New York, Ohio, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2099-2021 (May 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2099-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.