Randox Laboratories recalls
Randox Laboratories appears in 98 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro…
FDA Device · Class II · 2020-08-12 · Randox Laboratories
Reason: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. - Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quantitative in vitro d…
FDA Device · Class II · 2020-08-12 · Randox Laboratories
Reason: Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. - Chemistry QC Premium Plus, Cat
FDA Device · Class II · 2020-04-01 · Randox Laboratories
Reason: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. - RX Daytona Plus (with ISE/without ISE)
FDA Device · Class II · 2020-03-04 · Randox Laboratories
Reason: Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching… - Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
FDA Device · Class III · 2020-02-12 · Randox Laboratories
Reason: A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86). - Randox Liquid Cardiac Controls Catalogue Numbers CQ5053
FDA Device · Class II · 2019-11-27 · Randox Laboratories
Reason: Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. - Randox Liquid Cardiac Controls Catalogue Number CQ5051
FDA Device · Class II · 2019-11-27 · Randox Laboratories
Reason: Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. - Randox Liquid Cardiac Controls Catalogue Number CQ5052
FDA Device · Class II · 2019-11-27 · Randox Laboratories
Reason: Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. - RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066
FDA Device · Class III · 2019-11-20 · Randox Laboratories
Reason: Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing. - Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhance…
FDA Device · Class II · 2019-11-13 · Randox Laboratories
Reason: The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference materi… - Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are inten…
FDA Device · Class II · 2019-11-13 · Randox Laboratories
Reason: The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference materi… - Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control…
FDA Device · Class III · 2019-10-02 · Randox Laboratories
Reason: Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+. - This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays
FDA Device · Class III · 2019-09-18 · Randox Laboratories
Reason: Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE… - Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Device · Class III · 2019-08-14 · Randox Laboratories
Reason: The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL. - Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality cont…
FDA Device · Class II · 2019-08-14 · Randox Laboratories
Reason: The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls. - RX Imola, Model Nos
FDA Device · Class II · 2019-07-31 · Randox Laboratories
Reason: There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument. - RX Daytona, Model Nos
FDA Device · Class II · 2019-07-31 · Randox Laboratories
Reason: There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument. - Liquid Cardiac Control, Model Nos
FDA Device · Class II · 2019-06-26 · Randox Laboratories
Reason: Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI. - G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use,…
FDA Device · Class II · 2019-05-08 · Randox Laboratories
Reason: The target values and ranges in these lots are incorrect. - G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in…
FDA Device · Class II · 2019-05-08 · Randox Laboratories
Reason: The target values and ranges in these lots are incorrect. - Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assay…
FDA Device · Class III · 2019-04-17 · Randox Laboratories
Reason: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. - Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed q…
FDA Device · Class III · 2019-04-17 · Randox Laboratories
Reason: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. - Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as…
FDA Device · Class III · 2019-04-17 · Randox Laboratories
Reason: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U. - Randox Blood Gas Control Level 2 -Model BG5002
FDA Device · Class II · 2019-04-03 · Randox Laboratories
Reason: An error in the assignment of the control range pH in Blood Gas Control - Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clin…
FDA Device · Class II · 2019-03-27 · Randox Laboratories
Reason: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-a… - Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on cli…
FDA Device · Class II · 2019-03-27 · Randox Laboratories
Reason: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-a… - Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clin…
FDA Device · Class II · 2019-03-27 · Randox Laboratories
Reason: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-a… - Randox CALCIUM (Ca) Colorimetric Method RX Series Cat
FDA Device · Class II · 2019-02-27 · Randox Laboratories
Reason: Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely… - Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat
FDA Device · Class II · 2019-02-27 · Randox Laboratories
Reason: Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely… - SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, I…
FDA Device · Class II · 2019-01-02 · Randox Laboratories
Reason: Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected. - Liquid Cardiac Control, CQ5051
FDA Device · Class II · 2018-11-14 · Randox Laboratories
Reason: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable fo… - Liquid Cardiac Control, CQ5053
FDA Device · Class II · 2018-11-14 · Randox Laboratories
Reason: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable fo… - Liquid Cardiac Control, CQ5052
FDA Device · Class II · 2018-11-14 · Randox Laboratories
Reason: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable fo… - Liquid Cardiac Control - Level 3, cat. no
FDA Device · Class II · 2018-08-08 · Randox Laboratories
Reason: The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a dela… - Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no
FDA Device · Class II · 2018-07-04 · Randox Laboratories
Reason: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains result… - Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no
FDA Device · Class II · 2018-07-04 · Randox Laboratories
Reason: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains result… - Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no
FDA Device · Class II · 2018-07-04 · Randox Laboratories
Reason: The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls increase over the shelf life of the product. This may lead to a delay in reporting Free Kappa Light Chains result… - RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests
FDA Device · Class II · 2018-06-13 · Randox Laboratories
Reason: Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results. - Lipase, Catalog number: LI3837
FDA Device · Class II · 2018-05-16 · Randox Laboratories
Reason: Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments. - Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
FDA Device · Class III · 2018-03-21 · Randox Laboratories
Reason: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. - Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
FDA Device · Class III · 2018-03-21 · Randox Laboratories
Reason: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU. - Liquid Cardiac Control CQ5053
FDA Device · Class II · 2018-03-21 · Randox Laboratories
Reason: Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided contr… - Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD
FDA Device · Class II · 2018-01-03 · Randox Laboratories
Reason: Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product. - Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a ran…
FDA Device · Class III · 2017-06-07 · Randox Laboratories
Reason: According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a f… - The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocyst…
FDA Device · Class II · 2016-12-21 · Randox Laboratories
Reason: An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux… - Magnesium on RX Imola analyser IVD
FDA Device · Class II · 2016-12-14 · Randox Laboratories
Reason: According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wa… - Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum…
FDA Device · Class II · 2016-10-26 · Randox Laboratories
Reason: According to the firm carry over was observed when the Lipase test is run directly before or after the LDL and Triglycerides assays. Customers are instructed to amend the running order for all instruments using these re… - IgE Calibrator Series
FDA Device · Class II · 2016-10-12 · Randox Laboratories
Reason: According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control T…