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: 64, Class III: 13.
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.
Medical DeviceJan 24, 2024
Randox Laboratories Calibration Serum Level 3 - IVD For use as a Calibrator in clinical recall — FDA Z-0753-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 24, 2024
Randox Laboratories Calibration Serum Level 3 CAL2351 recall — FDA Z-0752-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 24, 2024
Randox Laboratories Calibration Serum Level 3 recall — FDA Z-0751-2024
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…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 10, 2024
Randox Laboratories SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro recall — FDA Z-0624-2024
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 IIIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceNov 8, 2023
Randox Laboratories RX Modena-IVD Clinical Chemistry Analyser recall — FDA Z-0201-2024
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceNov 8, 2023
Randox Laboratories RX Monaco-IVD Clinical Chemistry Analyser recall — FDA Z-0202-2024
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceNov 8, 2023
Randox Laboratories RX Imola-IVD Clinical Chemistry Analyzer recall — FDA Z-0200-2024
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceNov 8, 2023
Randox Laboratories RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser recall — FDA Z-0198-2024
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceNov 8, 2023
Randox Laboratories RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) recall — FDA Z-0199-2024
RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceSep 27, 2023
Randox Laboratories Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number recall — FDA Z-2609-2023
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceAug 30, 2023
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the recall — FDA Z-2448-2023
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibrators, IT2691, to reference…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceAug 30, 2023
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality recall — FDA Z-2446-2023
(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceAug 16, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref recall — FDA Z-2362-2023
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJul 5, 2023
Randox Laboratories Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality recall — FDA Z-2021-2023
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium…
Class IIIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJul 5, 2023
Randox Laboratories Immunoassay Premium Control Tri Level-In vitro diagnostic use, as recall — FDA Z-2022-2023
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium…
Class IIIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 11, 2023
Randox Laboratories Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic recall — FDA Z-0904-2023
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
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.