Randox Calibration Serum

• • Ongoing Z-1759-2024 FDA Class II ·initiated 5 Mar 2024

  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.

• • Ongoing Z-0753-2024 FDA Class II ·initiated 20 Nov 2023

  Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

• • Ongoing Z-0752-2024 FDA Class II ·initiated 20 Nov 2023

  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%.

• • Ongoing Z-0751-2024 FDA Class II ·initiated 13 Nov 2023

  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.

• • Terminated Z-1563-2021 FDA Class II ·initiated 29 Mar 2021

  Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

• • Terminated Z-2490-2019 FDA Class III ·initiated 12 Jul 2019

  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 onwards).

510(k) Number

K053153 ↗

FDA Product Code

JIX

FDA applicant

Randox Laboratories, Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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