169 results
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54ms
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Sources: EU EUDAMED, US FDA
RANDOX LABORATORIES-US, LTD
FDA registration
RANDOX LABORATORIES-US, LTD·2 products·🇺🇸 United States
LIQUID CARDIAC CONTROL LEVEL 3
FDA Adverse Event
Malfunction
·RANDOX LABORATORIES LTD·Product code JJY·October 3, 2018
LIQUID CARDIAC CONTROL LEVEL 1
FDA Adverse Event
Malfunction
·RANDOX LABORATORIES LTD·Product code JJY·October 3, 2018
ADVIA AMMONIA ASSAY
FDA Adverse Event
Malfunction
·RANDOX LABORATORIES, LTD.·Product code JJE·December 19, 2006
AMMONIA
FDA Adverse Event
Malfunction
·RANDOX LABORATORIES, LTD.·Product code JIF·April 13, 2015
AMMONIA
FDA Adverse Event
Malfunction
·RANDOX LABORATORIES, LTD.·Product code JIF·April 13, 2015
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.
FDA Enforcement
Class II
·Terminated·Response Biomedical Corp.·March 18, 2020
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
FDA Enforcement
Class II
·Terminated·Randox Laboratories Ltd.·January 3, 2018
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·February 13, 2019
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JIX·July 12, 2019
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP platform.
FDA Recall
Terminated
·Response Biomedical Corp.
1781 75th Ave W
Vancouver Canada·Product code JJY·March 15, 2019
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·November 22, 2022
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·November 22, 2022
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJY·November 22, 2022
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code JJE·April 5, 2024
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
FDA Recall
Terminated
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code LCP·June 7, 2017
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
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