NEFA CAL — Class II medical device recall Z-2099-2021
Terminated recall by Randox Laboratories Ltd., reported 2021-07-28, distributed nationwide. Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause
| Recall number | Z-2099-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2021-05-10 |
| Classified | 2021-07-20 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2021-11-10 |
| Distributed | Nationwide (US) |
| Quantity | 71 kits |
| UPC / GTIN / UDI-DI | 05055273203066 |
| Lot numbers | 28TH, 544642 |
| Model numbers | FA115 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2099-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.