NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for… recallZ-2099-2021 · Randox Laboratories Ltd. · initiated May 10, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
Randox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly. Letter states reason for recall, health risk, and action to take: Action to be taken: " Please discard previous value sheets and ensure standard value is updated. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director
Recall details
- Recall number
- Z-2099-2021
- Status
- Terminated
- Initiated by the company
- May 10, 2021
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 71 kits US
- Product code
- JLH
- Distribution
- US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
Product description
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Code information (models, lots, serial numbers)
Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Non-Esterified Fatty Acids (NEFA) FA115Randox Laboratories Limited · Conversion To Ferric Hydroxymates (Colorimetric), Fatty Acids2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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