Randox Laboratories, Limited Recalls

14 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (14)

December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Class II
December 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Class II
June 7, 2024
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Cystatin C Reagent marketed without a 510 (k)
Class II
April 5, 2024
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
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
Class III
March 5, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Class II
March 1, 2024
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Class II
February 14, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Class II
January 31, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Class II
January 31, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Class II
November 29, 2023
RX Series Copper (Cu) Assay Ref. Number CU2340
Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.
Class II
November 20, 2023
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Class II
November 20, 2023
Calibration Serum Level 3 CAL2351
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Class II
November 13, 2023
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
Class II
November 6, 2023
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxopla
A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Class III

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