FDA Device recall Z-2099-2021
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
- FDA Device
- Class II
- terminated
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115 by Randox Laboratories, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2099-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-10 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Reason
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
Identifiers
| code_info | Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2021%22
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