RANDOX NEFA — Class III medical device recall Z-0367-2020
Terminated recall by Randox Laboratories, Limited, reported 2019-11-20, distributed in WV. Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be u
| Recall number | Z-0367-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, N/A, United Kingdom |
| Recall initiated | 2019-09-23 |
| Classified | 2019-11-13 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2020-05-07 |
| Distributed | WV |
| UPC / GTIN / UDI-DI | 05055273203066 |
| Lot numbers | 485343 |
| Model numbers | FA115 |
| Expiration dates | 2019-03-20 |
Product
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Reason for recall
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
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-0367-2020. 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.