Randox Laboratories, Ltd.
Medical device manufacturer in Crumlin, GB.
133510(k) clearances
0PMA approvals
98recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 15
- JIX Calibrator, Multi-Analyte Mixture 5
- JJX Single (Specified) Analyte Controls… 5
- DJG Enzyme Immunoassay, Opiates 5
- DCK C-Reactive Protein, Antigen, Antiserum, And… 3
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 3
- DJR Enzyme Immunoassay, Methadone 3
- JIS Calibrator, Primary 3
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 3
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 2
- JHN Turbidimetric Method, Lipoproteins 2
- KHS Enzymatic, Carbon-Dioxide 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 2
- JGJ Photometric Method, Magnesium 2
- DKB Calibrators, Drug Mixture 2
- JFM Enzymatic Method, Bilirubin 2
- CGA Glucose Oxidase, Glucose 2
- DHR System, Test, Rheumatoid Factor 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 01/23/2026SE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 10/05/2023SE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | 10/05/2023SE |
| K230890 | ISE ElectrodesCEM · Special | 09/08/2023SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | 04/28/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | 04/21/2017SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | 03/20/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | 02/24/2016SE |
| K152343 | Direct BilirubinJFM · Traditional | 02/16/2016SE |
| K152344 | Total BilirubinJFM · Traditional | 01/28/2016SE |
| K153435 | Direct HDL Cholesterol (HDL)LBS · Traditional | 01/08/2016SE |
| K150654 | CholesterolCHH · Traditional | 09/29/2015SE |
| K150819 | TriglyceridesCDT · Traditional | 08/06/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | 12/08/2014SE |
| K142181 | Randox Aldolase Calibration SerumJIT · Traditional | 09/18/2014SE |
| K140522 | Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium…JJY · Traditional | 05/22/2014SE |
| K140393 | Randox Ammonia Ethanol Control Levels 1, 2 and Level 3JJY · Traditional | 03/25/2014SE |
| K131554 | RX Daytona Plus Chemistry Analyzer; RX Daytona Plus Aspartate Aminotransferase (Ast)…JJE · Traditional | 01/09/2014SE |
| K123977 | Randox Liquid Ck-Mb, Randox Ck-Mb CalibratorCGS · Traditional | 11/21/2013SE |
| K132156 | Randox CSF Controls Levels 2 and 3JJY · Traditional | 10/23/2013SE |
| K132090 | Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine…DLJ · Traditional | 08/08/2013SE |
| K131999 | HBA1C Control, Level 1 and Level 2JJX · Traditional | 07/26/2013SE |
| K131776 | Aldolase Controls Level 2, and Aldolase Control Level 3JJX · Traditional | 07/18/2013SE |
| K130337 | Randox Speciality Control (I) Levels 1, 2 and 3JJY · Traditional | 06/19/2013SE |
| K121603 | Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3JJY · Traditional | 11/20/2012SE |
| K113720 | Randox Maternal Control, Levels 1, 2 and 3JJY · Traditional | 09/20/2012SE |
| K113747 | Randox Opiates AssayDJG · Traditional | 08/24/2012SE |
| K122126 | Direct Ldl/Hdl Cholesterol CalibratorJIS · Traditional | 08/14/2012SE |
| K121746 | Randox Microalbumin Control Level 1 and Control Level 2 (Liquid)JJX · Traditional | 07/11/2012SE |
| K121588 | Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3JJX · Traditional | 06/20/2012SE |
| K113751 | Randox Cocaine MetaboliteDIO · Traditional | 05/08/2012SE |
| K110534 | Randox Liquid Cardiac Control Levels 1, 2 and 3JJY · Traditional | 01/23/2012SE |
| K112337 | Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri LevelJJY · Traditional | 12/01/2011SE |
| K102346 | Randox Digoxin AssayKXT · Traditional | 10/14/2011SE |
| K110904 | Randox Liquid Urine Control Levels 2 and 3JJY · Traditional | 09/30/2011SE |
| K110846 | Randox Urinalysis Controls, Levels 1 and 2JJW · Traditional | 09/30/2011SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | 05/25/2011SE |
| K092266 | Randox Methamphetamine AssayDKB · Traditional | 05/09/2011SE |
| K092269 | Cannabinoid Assay and the Randox Cannabinoid Calibrator/ Control SetLDJ · Traditional | 04/08/2011SE |
| K092275 | Randox Ecstasy (Mdma) AssayDKZ · Traditional | 03/01/2011SE |
| K092272 | Randox Methadone AssayDJR · Traditional | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | 11/09/2010SE |
| K092273 | Randox Ethanol AssayDIC · Traditional | 11/01/2010SE |
| K092274 | Randox Benzodiazepine AssayJXM · Traditional | 10/15/2010SE |
| K061056 | Randox Liquid Protein CalibratorJIX · Traditional | 07/20/2006SE |
| K052914 | RX ImolaCEM · Traditional | 03/31/2006SE |
| K053153 | Randox Calibration SerumJIX · Traditional | 01/13/2006SE |
| K050179 | Randox Benzodiazepine Class AssayJXM · Traditional | 05/17/2005SE |
| K043268 | Sodium Test Kit and Eletrolyte Cal 1 and 2CEI · Traditional | 02/15/2005SE |
| K043266 | Randox Urine ControlsJJW · Traditional | 02/15/2005SE |
| K043267 | Potassium Test Kit and Electrolyte Cal 1 and 2CEJ · Traditional | 02/10/2005SE |
| K043071 | Randox Phencyclidine AssayLCM · Traditional | 01/27/2005SE |
| K041142 | Randox Cannabinoids AsssayLDJ · Traditional | 11/23/2004SE |
| K041143 | Randox Barbiturate AssayDIS · Traditional | 11/05/2004SE |
| K041144 | Randox Opiates AssayDJG · Traditional | 11/03/2004SE |
| K041361 | Randox Tri Level Cardiac ControlJJY · Traditional | 09/09/2004SE |
| K040379 | Randox Immunoassay ControlJJY · Traditional | 06/16/2004SE |
| K033884 | Randox AmikacinKLQ · Traditional | 06/09/2004SE |
| K040350 | Randox Amphetamine Class AssayDKZ · Traditional | 05/12/2004SE |
| K040570 | Randox Methadone AssayDJR · Traditional | 05/10/2004SE |
| K040351 | Randox Liquid CRP ControlsJJX · Traditional | 03/12/2004SE |
| K033278 | Randox Uric AcidCDO · Traditional | 02/27/2004SE |
| K030360 | Randox EvidenceDIO · Traditional | 12/23/2003SE |
| K024014 | Randox RX DaytonaCGA · Traditional | 12/04/2003SE |
| K031608 | Randox Liquid Protein CalibratorJIX · Traditional | 08/08/2003SE |
| K030873 | Randox AmmoniaJIF · Traditional | 05/12/2003SE |
| K023763 | Randox Fructosamine, Fructosamine Calibrator, Fructosamine ControlsLCP · Traditional | 01/13/2003SE |
| K021897 | Randox Haemoglobin A1CLCP · Traditional | 11/26/2002SE |
| K022682 | Randox C-Reactive Protein CalibratorJIS · Traditional | 11/05/2002SE |
| K023158 | Randox Apolipoprotein CalibratorJIX · Traditional | 10/24/2002SE |
| K022591 | Randox Lipid ControlJJY · Traditional | 08/30/2002SE |
| K011771 | Randox TheophyllineKLS · Traditional | 01/17/2002SE |
| K011649 | Randox Valproic AcidLEG · Traditional | 01/15/2002SE |
| K011648 | Randox CarbamazepineKLT · Traditional | 01/15/2002SE |
| K012112 | Randox DigitoxinLFM · Traditional | 01/11/2002SE |
| K011393 | Randox PhenytoinDIP · Traditional | 12/04/2001SE |
| K011568 | Randox LipoproteinJIS · Traditional | 09/28/2001SE |
| K012978 | Randox GentamicinLCD · Traditional | 09/18/2001SE |
| K012318 | Randox Therapeutic Drug CalibratorDKB · Traditional | 09/12/2001SE |
| K012319 | Randox Human Asssayed Drug ControlDIF · Traditional | 08/24/2001SE |
| K011303 | Randox PhenobarbitalDLZ · Traditional | 07/02/2001SE |
| K011302 | Randox DigoxinKXT · Traditional | 07/02/2001SE |
| K010855 | Randox IgeDGC · Traditional | 05/15/2001SE |
| K010700 | Randox MyoglobinDDR · Traditional | 05/08/2001SE |
| K003346 | Randox Glucose (God/Pap)CGA · Traditional | 03/15/2001SE |
| K002585 | Randox TransferrinDDG · Traditional | 02/05/2001SE |
| K002674 | Randox MicroalbuminDDZ · Traditional | 10/05/2000SE |
| K001009 | Randox C-Reactive ProteinDCK · Traditional | 08/04/2000SE |
| K000661 | Randox PrealbuminJZJ · Traditional | 04/13/2000SE |
| K000375 | Randox CalciumCIC · Traditional | 04/05/2000SE |
| K000662 | Randox FerritinDBF · Traditional | 04/03/2000SE |
| K000483 | Randox AlbuminCJW · Traditional | 03/31/2000SE |
| K000469 | Randox Complement C3CZW · Traditional | 03/27/2000SE |
| K000468 | Randox Complement C4DBI · Traditional | 03/27/2000SE |
| K984494 | Randox AlbuminCIX · Traditional | 03/23/1999SE |
| K982529 | Randox Direct LDL CholesterolMRR · Traditional | 09/11/1998SE |
| K982341 | Direct Hdl-Cholestrol LiquidLBS · Traditional | 07/30/1998SE |
| K973993 | Randox CreatinineCGX · Traditional | 03/06/1998SE |
| K974606 | Randox MagnesiumJGJ · Traditional | 02/12/1998SE |
| K974607 | Randox CalciumCJY · Traditional | 02/02/1998SE |
| K974605 | Randox Inorganic PhosphorousCEO · Traditional | 01/09/1998SE |
| K974604 | Randox IronJMO · Traditional | 01/06/1998SE |
| K973995 | Randox BilirubinGIG · Traditional | 12/08/1997SE |
| K972220 | Rheumatoid Factor Latex-Enhanced Immunoturbidimetric Test KitDHR · Traditional | 09/09/1997SE |
| K972608 | Randox Assayed Specific Protein ControlJJY · Traditional | 08/04/1997SE |
| K971825 | Pancreatic Amylase, Ethylidene BLOCKED-PNPG7 Enzyme Colorimetric TestJFJ · Traditional | 07/24/1997SE |
| K970735 | Boehringer Mannheim Direct Hdl-CholesterolLBS · Traditional | 06/06/1997SE |
| K970684 | Lactate Dehydrogenase (LD)CFJ · Traditional | 05/07/1997SE |
| K953210 | Glucose (Hexokinase) KitCFR · Traditional | 10/25/1996SE |
| K961169 | Rheumatoid Factor Latex Slide Test KitDHR · Traditional | 06/26/1996SE |
| K955489 | Calibration Serum Level 1 & 2JIX · Traditional | 06/21/1996SE |
| K953211 | Amylase (Ethylidene PNGPG7) KitCIJ · Traditional | 06/21/1996SE |
| K951222 | Total Protein (Urine)JIR · Traditional | 04/24/1996SE |
| K955798 | Igg Immunoturbidimetric & CalibratorDEW · Traditional | 04/05/1996SE |
| K955797 | Igm Immunotrubidimetric & CalibratorDFT · Traditional | 04/05/1996SE |
| K955794 | Iga Immunoturbidimetric & CalibratorCZP · Traditional | 04/05/1996SE |
| K951221 | Total CO2KHS · Traditional | 02/15/1996SE |
| K951223 | Ck-Mb (Nac-Act)CGS · Traditional | 12/26/1995SE |
| K954447 | C-Reactive Protein Latex KitDCK · Traditional | 12/18/1995SE |
| K950383 | Apolipoprotein A-I Immunoturbidimetric KitJHN · Traditional | 09/15/1995SE |
| K950382 | Apolipoprotein B Immunoturbidiemetric KitJHN · Traditional | 09/15/1995SE |
| K953212 | C-Reactive Protein Immunoturbidimetric Kit & CRP CalibratorDCK · Traditional | 07/31/1995SE |
| K942458 | Precision-Multi-Sera - Human - Normal and ElevatedJJY · Traditional | 03/13/1995SE |
| K923504 | Cholesterol Enzymatic EndpointCHH · Traditional | 01/10/1994SE |
| K923506 | Urea KitCDQ · Traditional | 09/27/1993SE |
| K923508 | Triglycerides Gpo-PapCDT · Traditional | 07/28/1993SE |
| K923503 | Uric Acid Enzymatic Colorimeric KitKNK · Traditional | 07/22/1993SE |
| K923509 | Gamma-GtJPZ · Traditional | 12/03/1992SE |
| K923507 | Alkaline Phosphatase KitCJE · Traditional | 12/03/1992SE |
| K923510 | Alt (GPT) - Alanine AminotransferaseCKA · Traditional | 11/16/1992SE |
| K923505 | Ast (Got) - Aspartate AminotransferaseCIT · Traditional | 11/16/1992SE |
| K923511 | Ck-Nac Activated KitCGS · Traditional | 10/15/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1018-2025 Class II | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay…Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | 12/20/2024Open, Classified |
| Z-1017-2025 Class II | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay…Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. | 12/20/2024Open, Classified |
| Z-2425-2024 Class II | RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox…Cystatin C Reagent marketed without a 510 (k) | 06/07/2024Open, Classified |
| Z-1786-2024 Class III | Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative…Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not… | 04/05/2024Open, Classified |
| Z-1759-2024 Class II | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized…Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 &… | 03/05/2024Open, Classified |
| Z-1328-2024 Class II | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with…The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material… | 03/01/2024Open, Classified |
| Z-1369-2024 Class II | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox…Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods | 02/14/2024Open, Classified |
| Z-1594-2024 Class II | Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay…Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method… | 01/31/2024Open, Classified |
| Z-1593-2024 Class II | Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay…Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods… | 01/31/2024Open, Classified |
| Z-0992-2024 Class II | RX Series Copper (Cu) Assay Ref. Number CU2340Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that… | 11/29/2023Open, Classified |
| Z-0753-2024 Class II | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays…Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the… | 11/20/2023Open, Classified |
| Z-0752-2024 Class II | Calibration Serum Level 3 CAL2351CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments… | 11/20/2023Open, Classified |
| Z-0751-2024 Class II | Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530)…There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3… | 11/13/2023Open, Classified |
| Z-0624-2024 Class III | SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for…A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on… | 11/06/2023Open, Classified |
| Z-0501-2024 Class II | RANDOX Total Bilirubin.Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total… | 10/11/2023Open, Classified |
| Z-0202-2024 Class II | RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample… | 09/06/2023Open, Classified |
| Z-0201-2024 Class II | RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample… | 09/06/2023Open, Classified |
| Z-0200-2024 Class II | RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample… | 09/06/2023Open, Classified |
| Z-0199-2024 Class II | RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R…RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample… | 09/06/2023Open, Classified |
| Z-0198-2024 Class II | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample… | 09/06/2023Open, Classified |
| Z-2609-2023 Class II | Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry… | 08/03/2023Open, Classified |
| Z-2448-2023 Class II | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the…As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories… | 07/19/2023Open, Classified |
| Z-2446-2023 Class II | Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the…(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be… | 06/21/2023Open, Classified |
| Z-2362-2023 Class II | Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3)…Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to… | 06/13/2023Open, Classified |
| Z-2022-2023 Class III | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality…Delay in reporting results due to Quality Controls running high outside of range. Target value and range for… | 05/04/2023Open, Classified |
| Z-2021-2023 Class III | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material…Delay in reporting results due to Quality Controls running high outside of range. Target value and range for… | 05/04/2023Open, Classified |
| Z-1286-2023 Class II | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of…The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples.… | 02/01/2023Open, Classified |
| Z-0905-2023 Class II | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | 11/22/2022Open, Classified |
| Z-0904-2023 Class II | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | 11/22/2022Open, Classified |
| Z-0903-2023 Class II | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | 11/22/2022Open, Classified |
| Z-0363-2023 Class II | IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma…Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run… | 11/01/2022Terminated |
| Z-0362-2023 Class II | IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma…Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run… | 11/01/2022Terminated |
| Z-1772-2022 Class II | The Randox Serology I Positive Control contains the following analytes in human based…***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter… | 08/01/2022Terminated |
| Z-1424-2022 Class II | Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum…Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating… | 06/22/2022Terminated |
| Z-1423-2022 Class III | Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVDA customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an… | 06/09/2022Terminated |
| Z-1422-2022 Class III | Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVDA customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an… | 06/09/2022Terminated |
| Z-1097-2022 Class III | CK MB Calibrator, Catalogue Number CK2393Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause… | 03/25/2022Terminated |
| Z-0328-2022 Class II | RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma…When calibrating using the standard provided in the kit, the change in absorbance is lower than expected… | 11/01/2021Terminated |
| Z-2099-2021 Class II | NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog…Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will… | 05/10/2021Terminated |
| Z-2013-2021 Class II | Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900RAn issue was identified where the software froze during processing of commands, which resulted in no results… | 04/28/2021Terminated |
| Z-1563-2021 Class II | Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number:…Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay… | 03/29/2021Terminated |
| Z-0547-2021 Class II | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of…Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by… | 11/13/2020Terminated |
| Z-0546-2021 Class II | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium…Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by… | 11/13/2020Terminated |
| Z-2963-2020 Class II | Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended…An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover… | 08/11/2020Terminated |
| Z-2962-2020 Class II | Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device…An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover… | 08/11/2020Terminated |
| Z-2966-2020 Class II | AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro…Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being… | 07/30/2020Terminated |
| Z-2965-2020 Class II | AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro…Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140mol/l being… | 07/30/2020Terminated |
| Z-2924-2020 Class II | Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 ReagentAmylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted… | 07/10/2020Terminated |
| Z-2923-2020 Class II | Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 ReagentAmylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted… | 07/10/2020Terminated |
| Z-2753-2020 Class II | Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test…Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase… | 06/26/2020Terminated |
| Z-2752-2020 Class II | Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system…Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase… | 06/26/2020Terminated |
| Z-2751-2020 Class II | Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system…Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase… | 06/26/2020Terminated |
| Z-1547-2020 Class II | Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This…The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. | 02/18/2020Open, Classified |
| Z-1349-2020 Class II | RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without…Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1)… | 12/19/2019Terminated |
| Z-1100-2020 Class III | Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 mlA transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry… | 12/13/2019Terminated |
| Z-0414-2020 Class II | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed… | 10/04/2019Terminated |
| Z-0413-2020 Class II | Randox Liquid Cardiac Controls Catalogue Number CQ5052.Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed… | 10/04/2019Terminated |
| Z-0412-2020 Class II | Randox Liquid Cardiac Controls Catalogue Number CQ5051Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed… | 10/04/2019Terminated |
| Z-0367-2020 Class III | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be… | 09/23/2019Terminated |
| Z-0283-2020 Class II | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032…The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British… | 08/09/2019Terminated |
| Z-0282-2020 Class II | Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039…The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British… | 08/09/2019Terminated |
| Z-2557-2019 Class III | Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended…Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected… | 07/25/2019Terminated |
| Z-2490-2019 Class III | This is an in vitro diagnostic product intended for use as a calibration serum in…Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line… | 07/12/2019Terminated |
| Z-2084-2019 Class II | RX Imola, Model Nos. RX4900There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to… | 06/24/2019Terminated |
| Z-2083-2019 Class II | RX Daytona, Model Nos. RX4040 and RX4041There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to… | 06/24/2019Terminated |
| Z-2150-2019 Class II | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is…The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT… | 06/11/2019Terminated |
| Z-2207-2019 Class III | Assayed Bovine Multi-Sera Level 1, Model No. AL1027The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation… | 06/10/2019Terminated |
| Z-1255-2019 Class II | G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This…The target values and ranges in these lots are incorrect. | 04/03/2019Terminated |
| Z-1254-2019 Class II | G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage:…The target values and ranges in these lots are incorrect. | 04/03/2019Terminated |
| Z-1785-2019 Class II | Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac… | 03/11/2019Terminated |
| Z-1057-2019 Class II | Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of…An error in the assignment of the control range pH in Blood Gas Control | 02/13/2019Terminated |
| Z-1107-2019 Class III | Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | 02/07/2019Terminated |
| Z-1106-2019 Class III | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | 02/07/2019Terminated |
| Z-1105-2019 Class III | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | 02/07/2019Terminated |
| Z-0840-2019 Class II | Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo…Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover… | 12/04/2018Terminated |
| Z-0839-2019 Class II | Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent…Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover… | 12/04/2018Terminated |
| Z-1018-2019 Class II | Fructosamine Control 3, FR2996 This product is intended for in vitro use in the…The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control… | 12/03/2018Open, Classified |
| Z-1017-2019 Class II | Fructosamine Control 1, FR2994 This product is intended for in vitro use in the…The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control… | 12/03/2018Open, Classified |
| Z-1016-2019 Class II | Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the…The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control… | 12/03/2018Open, Classified |
| Z-0660-2019 Class II | SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with…Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and… | 11/19/2018Terminated |
| Z-0382-2019 Class II | Liquid Cardiac Control, CQ5053Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8… | 10/02/2018Terminated |
| Z-0381-2019 Class II | Liquid Cardiac Control, CQ5052Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8… | 10/02/2018Terminated |
| Z-0380-2019 Class II | Liquid Cardiac Control, CQ5051Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8… | 10/02/2018Terminated |
| Z-2575-2018 Class II | Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is…The device is not suitable for the control of the Troponin T assay due to unacceptable variation between… | 06/08/2018Terminated |
| Z-2280-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | 05/22/2018Terminated |
| Z-2279-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | 05/22/2018Terminated |
| Z-2278-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | 05/22/2018Terminated |
| Z-2059-2018 Class II | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of…Abnormal premature termination of the software could affect the use of the analyser when running patient… | 05/04/2018Terminated |
| Z-1631-2018 Class II | Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN:…Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments. | 03/02/2018Terminated |
| Z-0970-2018 Class III | Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted… | 08/11/2017Terminated |
| Z-0969-2018 Class III | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted… | 08/11/2017Terminated |
| Z-0937-2018 Class II | Liquid Cardiac Control CQ5053Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does… | 08/08/2017Terminated |
| Z-0285-2018 Class II | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX…Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may… | 06/07/2017Terminated |
| Z-2167-2017 Class III | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of…According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods… | 04/27/2017Terminated |
| Z-0762-2017 Class II | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls…An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for… | 09/16/2016Terminated |
| Z-0050-2017 Class II | IgE Calibrator SeriesAccording to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been… | 09/07/2016Terminated |
| Z-0123-2017 Class II | Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to…According to the firm carry over was observed when the Lipase test is run directly before or after the LDL… | 08/02/2016Terminated |
| Z-0725-2017 Class II | Magnesium on RX Imola analyser IVDAccording to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly… | 04/14/2016Terminated |