13 results · 53ms · Sources: EU EUDAMED, US FDA

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RX Daytona, Model Nos. RX4040 and RX4041

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJE·June 24, 2019

Randox Liquid Cardiac Controls Catalogue Number CQ5051

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·October 4, 2019

Randox Liquid Cardiac Controls Catalogue Number CQ5052.

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·October 4, 2019

Magnesium on RX Imola analyser IVD

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JGJ·April 14, 2016

Liquid Cardiac Control CQ5053

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JJY·August 8, 2017

RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JLG·September 23, 2019

RX Imola, Model Nos. RX4900

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJE·June 24, 2019

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

FDA Recall
Open, Classified ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·June 10, 2019

Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·October 4, 2019

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.

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJE·December 19, 2019

Human 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.

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJY·June 11, 2019

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

FDA Recall
Open, Classified ·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code DFC·December 20, 2024