Food, drugs, devices › Randox Laboratories, Limited
Device recall: RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully aut
Randox Laboratories, Limited (Crumlin, N/A) initiated this device recall on 19 Dec 2019; FDA lists 1 product record under event 84649, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 23 Apr 2021. 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
"Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range.""
Distribution
"US Nationwide distribution including state of PR."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1349-2020 | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories. | U.S.: RX4040-2 units RX 4041-3 units | Class II | Terminated | 4 Mar 2020 |
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 |
| 4 Oct 2019 | Randox Liquid Cardiac Controls Catalogue Number CQ5051 | Device | Class II | 3 |
| 23 Sep 2019 | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. | Device | Class III | 1 |
| 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: "Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range.""
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution including state of PR."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Apr 2021. "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.