Medical DeviceJul 31, 2024
Randox Laboratories RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic recall — FDA Z-2425-2024
Cystatin C Reagent marketed without a 510 (k)
Class IIFDA: OngoingRandox Laboratories Ltd.
Recall history in this database
Classification mix: Class II: 7, Class III: 1.
Medical DeviceMay 15, 2024
Randox Laboratories Evidence MultiSTAT with software v 3.7-Analyzer intended for the recall — FDA Z-1786-2024
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…
Class IIIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceMay 15, 2024
Randox Laboratories Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is recall — FDA Z-1759-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceApr 24, 2024
Randox Laboratories Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the recall — FDA Z-1593-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceApr 24, 2024
Randox Laboratories Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the recall — FDA Z-1594-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceApr 3, 2024
Randox Laboratories Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration recall — FDA Z-1369-2024
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceMar 27, 2024
Randox Laboratories Liquid Protein Calibrators recall — FDA Z-1328-2024
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceFeb 14, 2024
Randox Laboratories RX Series Copper (Cu) Assay Ref recall — FDA Z-0992-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Understanding this recall history
This page summarizes recall records in which the official source identifies Randox Laboratories Ltd. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.