Food, drugs, devices › Randox Laboratories, Limited
Device recall: RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Randox Laboratories, Limited (Crumlin, N/A) initiated this device recall on 23 Sep 2019; FDA lists 1 product record under event 84007, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 7 May 2020. Initiation: voluntary: firm initiated. Randox Laboratories, Limited has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Randox Laboratories, Limited, Crumlin, N/A, United Kingdom.
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."
Distribution
"WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0367-2020 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | 212 (19 US; 193 OUS) | Class III | Terminated | 20 Nov 2019 |
Context
Other enforcement events for Randox Laboratories, Limited
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Dec 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog N | Device | Class II | 2 |
| 19 Dec 2019 | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully aut | Device | Class II | 1 |
| 4 Oct 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Device | Class II | 3 |
| 24 Jun 2019 | RX Daytona, Model Nos. RX4040 and RX4041 | Device | Class II | 2 |
| 11 Jun 2019 | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, | Device | Class II | 1 |
| 10 Jun 2019 | Assayed Bovine Multi-Sera Level 1, Model No. AL1027 | Device | Class III | 1 |
| 8 Aug 2017 | Liquid Cardiac Control CQ5053 | Device | Class II | 1 |
| 14 Apr 2016 | Magnesium on RX Imola analyser IVD | Device | Class II | 1 |
All 9 events for Randox Laboratories, Limited
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "WV (USA), International: GB, BE, CZ, FR, GR, IE, IT, NL, PL, SK, ES, CH, TR, AU, BR, MX, RU, SG, TW"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.