Randox Laboratories Ltd. FDA Recalls

38 recalls on file across devices, 0 of them Class I and 27 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated aClass IIJun 7, 2024Cystatin C Reagent marketed without a 510 (k)	Cystatin C Reagent marketed without a 510 (k)	Class IIDevices	Jun 7, 2024
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and Class IIIApr 5, 2024Foam gasket on the Evidence MultiSTAT chip heater assembly m	Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not funct	Class IIIDevices	Apr 5, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 cClass IIMar 5, 2024Randox Laboratories has identified that Inorganic Phosphate	Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL103	Class IIDevices	Mar 5, 2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays thatClass IIMar 1, 2024The firm has realigned C3 and Haptoglobin in Liquid Protein	The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA4	Class IIDevices	Mar 1, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated anaClass IIFeb 14, 2024Cystatin C Calibrator Series CVS 2699, is running with a neg	Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods	Class IIDevices	Feb 14, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426Class IIJan 31, 2024Microalbumin Calibrator Series, MA1567 & MA2426, is running	Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may	Class IIDevices	Jan 31, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567Class IIJan 31, 2024Microalbumin Calibrator Series, MA1567 & MA2426, is running	Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and	Class IIDevices	Jan 31, 2024
RX Series Copper (Cu) Assay Ref. Number CU2340Class IINov 29, 2023Randox Laboratories have released an update to the Carryover	Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Coppe	Class IIDevices	Nov 29, 2023
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351Class IINov 20, 2023Target for Alkaline Phosphatase (ALP) for the AMP optimized	Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the	Class IIDevices	Nov 20, 2023
Calibration Serum Level 3 CAL2351Class IINov 20, 2023CK Total in Calibration Serum Level 3, CAL2351, is running w	CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compa	Class IIDevices	Nov 20, 2023
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level Class IINov 13, 2023There have been transcription errors on the Instructions For	There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2	Class IIDevices	Nov 13, 2023
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to CClass IIINov 6, 2023A decrease in the reactivity of HSV Type 1/2 lgM in the Sero	A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the	Class IIIDevices	Nov 6, 2023
RANDOX Total Bilirubin.Class IIOct 11, 2023Randox has had reports of elevated patient results using Pla	Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin	Class IIDevices	Oct 11, 2023
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040Class IISep 6, 2023RX Parameter rerun settings (Sample Volume Low/High), and Di	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample	Class IIDevices	Sep 6, 2023
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000Class IISep 6, 2023RX Parameter rerun settings (Sample Volume Low/High), and Di	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample	Class IIDevices	Sep 6, 2023
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000Class IISep 6, 2023RX Parameter rerun settings (Sample Volume Low/High), and Di	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample	Class IIDevices	Sep 6, 2023
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)Class IISep 6, 2023RX Parameter rerun settings (Sample Volume Low/High), and Di	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample	Class IIDevices	Sep 6, 2023
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)Class IISep 6, 2023RX Parameter rerun settings (Sample Volume Low/High), and Di	RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample	Class IIDevices	Sep 6, 2023
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215Class IIAug 3, 2023there has been a transcription error in the Instructions for	there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Contro	Class IIDevices	Aug 3, 2023
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement CClass IIJul 19, 2023As part of the firm's ongoing quality monitoring (see inter	As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories hav	Class IIDevices	Jul 19, 2023
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, CClass IIJun 21, 2023(1) There is vial to vial variation resulting in some vials	(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negat	Class IIDevices	Jun 21, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (ModenaClass IIJun 13, 2023Carryover from the Direct LDL-cholesterol assay on the Rx in	Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11	Class IIDevices	Jun 13, 2023
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and repClass IIIMay 4, 2023Delay in reporting results due to Quality Controls running h	Delay in reporting results due to Quality Controls running high outside of range. Target value and range for	Class IIIDevices	May 4, 2023
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuraClass IIIMay 4, 2023Delay in reporting results due to Quality Controls running h	Delay in reporting results due to Quality Controls running high outside of range. Target value and range for A	Class IIIDevices	May 4, 2023
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immuClass IINov 22, 2022Concentration of Rheumatoid Factor has decreased in Specific	Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in report	Class IIDevices	Nov 22, 2022
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical cClass IINov 22, 2022Concentration of Rheumatoid Factor has decreased in Specific	Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in report	Class IIDevices	Nov 22, 2022
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chClass IINov 22, 2022Concentration of Rheumatoid Factor has decreased in Specific	Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in report	Class IIDevices	Nov 22, 2022
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832Class IINov 1, 2022Update to the carryover avoidance technical bulletin to deta	Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immed	Class IIDevices	Nov 1, 2022
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834Class IINov 1, 2022Update to the carryover avoidance technical bulletin to deta	Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immed	Class IIDevices	Nov 1, 2022
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/Class IIAug 1, 2022*Update :HBsAg analyte is also Non-Reactive on the Ortho	*Update :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter Dx	Class IIDevices	Aug 1, 2022
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CHClass IIJun 22, 2022Product fails to meet the performance claims quoted on the k	Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using	Class IIDevices	Jun 22, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVDClass IIIJun 9, 2022A customer reported a problem with the reagent and calibrato	A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigatio	Class IIIDevices	Jun 9, 2022
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVDClass IIIJun 9, 2022A customer reported a problem with the reagent and calibrato	A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigatio	Class IIIDevices	Jun 9, 2022
CK MB Calibrator, Catalogue Number CK2393Class IIIMar 25, 2022Randox have realigned CK-MB Calibrator, CK2393, lot number 4	Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a	Class IIIDevices	Mar 25, 2022
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200Class IINov 1, 2021When calibrating using the standard provided in the kit, the	When calibrating using the standard provided in the kit, the change in absorbance is lower than expected gener	Class IIDevices	Nov 1, 2021
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115Class IIMay 10, 2021Standard packed within NEFA kit has been assigned incorrect	Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will caus	Class IIDevices	May 10, 2021
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900RClass IIApr 28, 2021An issue was identified where the software froze during proc	An issue was identified where the software froze during processing of commands, which resulted in no results d	Class IIDevices	Apr 28, 2021
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351Class IIMar 29, 2021Randox can confirm a positive bias for Total Bilirubin and D	Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ran	Class IIDevices	Mar 29, 2021