| 2024-12-20 |
Class II
|
Ongoing |
Z-1018-2025 |
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo… |
— |
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| 2024-12-20 |
Class II
|
Ongoing |
Z-1017-2025 |
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal… |
— |
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| 2024-06-07 |
Class II
|
Ongoing |
Z-2425-2024 |
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated a… |
— |
Cystatin C Reagent marketed without a 510 (k) |
| 2024-04-05 |
Class III
|
Ongoing |
Z-1786-2024 |
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and … |
— |
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 th… |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1759-2024 |
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 c… |
— |
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series i… |
| 2024-03-01 |
Class II
|
Ongoing |
Z-1328-2024 |
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that… |
— |
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. |
| 2024-02-14 |
Class II
|
Ongoing |
Z-1369-2024 |
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated ana… |
— |
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods |
| 2024-01-31 |
Class II
|
Ongoing |
Z-1594-2024 |
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 … |
| 2024-01-31 |
Class II
|
Ongoing |
Z-1593-2024 |
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 exper… |
| 2023-11-29 |
Class II
|
Ongoing |
Z-0992-2024 |
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,… |
| 2023-11-20 |
Class II
|
Ongoing |
Z-0753-2024 |
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 Qua… |
| 2023-11-20 |
Class II
|
Ongoing |
Z-0752-2024 |
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… |
| 2023-11-13 |
Class II
|
Ongoing |
Z-0751-2024 |
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level … |
— |
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 valu… |
| 2023-11-06 |
Class III
|
Ongoing |
Z-0624-2024 |
SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to C… |
— |
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. |
| 2023-10-11 |
Class II
|
Ongoing |
Z-0501-2024 |
RANDOX Total Bilirubin. |
— |
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0202-2024 |
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000 |
— |
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 … |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0201-2024 |
RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000 |
— |
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 … |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0200-2024 |
RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished) |
— |
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 … |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0199-2024 |
RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished) |
— |
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 … |
| 2023-09-06 |
Class II
|
Ongoing |
Z-0198-2024 |
RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040 |
— |
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 … |
| 2023-08-03 |
Class II
|
Ongoing |
Z-2609-2023 |
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 |
— |
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 on… |
| 2023-07-19 |
Class II
|
Ongoing |
Z-2448-2023 |
Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C… |
— |
As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein Calibr… |
| 2023-06-21 |
Class II
|
Ongoing |
Z-2446-2023 |
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, C… |
— |
(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. (… |
| 2023-06-13 |
Class II
|
Ongoing |
Z-2362-2023 |
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena… |
— |
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… |
| 2023-05-04 |
Class III
|
Ongoing |
Z-2022-2023 |
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accura… |
— |
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 20… |
| 2023-05-04 |
Class III
|
Ongoing |
Z-2021-2023 |
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and rep… |
— |
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 2… |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1286-2023 |
CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cat… |
— |
The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be wit… |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0905-2023 |
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical ch… |
— |
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low ou… |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0904-2023 |
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical c… |
— |
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low ou… |
| 2022-11-22 |
Class II
|
Ongoing |
Z-0903-2023 |
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immu… |
— |
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low ou… |
| 2022-11-01 |
Class II
|
Terminated |
Z-0363-2023 |
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834 |
— |
Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 … |
| 2022-11-01 |
Class II
|
Terminated |
Z-0362-2023 |
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832 |
— |
Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 … |
| 2022-08-01 |
Class II
|
Terminated |
Z-1772-2022 |
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/… |
— |
***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test n… |
| 2022-06-22 |
Class II
|
Terminated |
Z-1424-2022 |
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH… |
— |
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in a… |
| 2022-06-09 |
Class III
|
Terminated |
Z-1423-2022 |
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD |
— |
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertai… |
| 2022-06-09 |
Class III
|
Terminated |
Z-1422-2022 |
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD |
— |
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertai… |
| 2022-03-25 |
Class III
|
Terminated |
Z-1097-2022 |
CK MB Calibrator, Catalogue Number CK2393 |
— |
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Qual… |
| 2021-11-01 |
Class II
|
Terminated |
Z-0328-2022 |
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 |
— |
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outsid… |
| 2021-05-10 |
Class II
|
Terminated |
Z-2099-2021 |
NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115 |
— |
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality … |
| 2021-04-28 |
Class II
|
Terminated |
Z-2013-2021 |
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R |
— |
An issue was identified where the software froze during processing of commands, which resulted in no results displayed. |
| 2021-03-29 |
Class II
|
Terminated |
Z-1563-2021 |
Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351 |
— |
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… |
| 2020-11-13 |
Class II
|
Terminated |
Z-0547-2021 |
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine… |
— |
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine |
| 2020-11-13 |
Class II
|
Terminated |
Z-0546-2021 |
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catal… |
— |
Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine |
| 2020-08-11 |
Class II
|
Terminated |
Z-2963-2020 |
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro de… |
— |
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX… |
| 2020-08-11 |
Class II
|
Terminated |
Z-2962-2020 |
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in v… |
— |
An update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Lactate Dehydrogenase assay on RX… |
| 2020-07-30 |
Class II
|
Terminated |
Z-2966-2020 |
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma |
— |
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. |
| 2020-07-30 |
Class II
|
Terminated |
Z-2965-2020 |
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma |
— |
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. |
| 2020-07-10 |
Class II
|
Terminated |
Z-2924-2020 |
Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent |
— |
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
| 2020-07-10 |
Class II
|
Terminated |
Z-2923-2020 |
Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent |
— |
Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
| 2020-06-26 |
Class II
|
Terminated |
Z-2753-2020 |
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the… |
— |
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches. |
| 2020-06-26 |
Class II
|
Terminated |
Z-2752-2020 |
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the qu… |
— |
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches. |
| 2020-06-26 |
Class II
|
Terminated |
Z-2751-2020 |
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quan… |
— |
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. |
| 2020-02-18 |
Class II
|
Ongoing |
Z-1547-2020 |
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro … |
— |
The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. |