Recall Register

Randox Laboratories, Limited: FDA recalls

FDA enforcement reports name Randox Laboratories, Limited as the recalling firm in 9 events. The events have 13 product records. The recalls started from 2016 to 2024. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

9 events, newest first.

FDA enforcement events of Randox Laboratories, Limited
InitiatedProduct (first record)TypeClassRecordsStatus
20 Dec 2024Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403DeviceClass II2Ongoing
19 Dec 2019RX 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.DeviceClass II1Terminated
4 Oct 2019Randox Liquid Cardiac Controls Catalogue Number CQ5051DeviceClass II3Terminated
23 Sep 2019RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.DeviceClass III1Terminated
24 Jun 2019RX Daytona, Model Nos. RX4040 and RX4041DeviceClass II2Terminated
11 Jun 2019Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.DeviceClass II1Terminated
10 Jun 2019Assayed Bovine Multi-Sera Level 1, Model No. AL1027DeviceClass III1Terminated
8 Aug 2017Liquid Cardiac Control CQ5053DeviceClass II1Terminated
14 Apr 2016Magnesium on RX Imola analyser IVDDeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Randox Laboratories, Limited: events for each product type
TypeEvents
Device9
Randox Laboratories, Limited: events in each class
ClassEvents
Class II7
Class III2
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
1

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Randox Laboratories, Limited, by the year that the recall started. The largest year is 2019, with 6 events.

Official channels

Cite this page

Recall Register. Randox Laboratories, Limited: FDA recalls. https://recallregister.com/firm/randox-laboratories-limited/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Randox Laboratories, Limited have?
Class II: 7 events. Class III: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Randox Laboratories, Limited?
FDA event 96043, which the firm started on 20 Dec 2024. The first product in the record is: Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
How many FDA recalls of Randox Laboratories, Limited have the status Ongoing?
1 event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.