# FDA recall Z-2099-2021

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2021-05-10.

## Product

NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA  Catalog Number: FA115

## Reason for recall

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

## Distribution

US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX

## Key facts

- **Recall number:** Z-2099-2021
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-10
- **Report date:** 2021-07-28
- **Termination date:** 2021-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2021

## Citation

> AI Analytics. FDA recall Z-2099-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2099-2021. Source: US FDA. Licensed CC0.

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