Randox Laboratories Ltd.: Medical Device Recalls in 2023

According to to data from the FDA, there were 15 medical device recalls made by Randox Laboratories Ltd. in 2023. See the details of the recalls below.

You can see similar recalls for other firms.

• 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
• 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
• RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
• RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
• RANDOX Total Bilirubin.
• 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
• Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
• Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
• Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
• RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
• Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
• RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
• RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
• Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
• Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074