Randox Laboratories recalls
27 official recalls and safety alerts involving Randox Laboratories since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Randox Laboratories or the relevant agency.
- 2025-01-29
USRandox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- 2024-07-31
- US
Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers.…
Cystatin C Reagent marketed without a 510 (k)
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of AL, CA, GA, NY.Official notice → - 2024-05-15
- US
Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of…
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 (CCD) Camera during imaging. This…
- US
Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used…
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.
- 2024-04-24
- US
Randox Laboratories Ltd. recalls 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 experience a shift in Quality Control and patient sample…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of GA, MA, WV including PR.Official notice → - 2024-04-03
- US
Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog…
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of CA, IN.Official notice → - 2024-03-27
- US
Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample…
The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.
- 2024-02-14
- US
Randox Laboratories Ltd. recalls 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, on the RX series instruments testing order. If copper…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of SC and OK.Official notice → - 2024-01-24
- US
Randox Laboratories Ltd. recalls 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 Quality Control and patient samples
- US
Randox Laboratories Ltd. recalls 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 Control and patient sample recovery of up to 13%.
- US
Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
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…
- 2024-01-10
- US
Randox Laboratories Ltd. recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus…
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.
- 2023-12-13
- US
Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of AR, GA, NC, TN, & PR.Official notice → - 2023-11-08
- US
Randox Laboratories Ltd. recalls 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 assay range and may result i issues with the re-run feature…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution including Puerto RicoOfficial notice → - 2023-09-27
- US
Randox Laboratories Ltd. recalls 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 one and two standard deviation values printed on the sheet…
- 2023-08-30
- US
Randox Laboratories Ltd. recalls Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement…
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 material NISBC 19/118. The…
- US
Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride,…
(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 transcription error for Creatinine in…
FDA · DeviceRandox Laboratories Ltd.Worldwide distribution - US Nationwide distribution in the states of AR, FL,…Official notice → - 2023-08-16
- US
Randox Laboratories Ltd. recalls 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 assays results if the urea assay is run immediately after…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of CA, DC, GA, OH, OK, MN, MO, NJ, VA…Official notice → - 2023-07-05
- US
Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of…
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 Control Tri Level kit batch…
- 2023-04-05
- US
Randox Laboratories recalls CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826
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 within range
- 2023-01-11
- US
Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and…
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
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.Official notice → - 2022-12-14
- US
Randox Laboratories Ltd. recalls 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 or FR4030 on the RX instruments testing order. Can lead to…
- 2022-09-28
- US
Randox Laboratories Ltd. recalls The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV,…
***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 negative (Non-Reactive) for Marker HBsAg resulting in delay…
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of WV, NC.Official notice → - 2022-07-27
- US
Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
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 absorbance is lower than expected generating internal…
- US
Randox Laboratories Ltd. recalls 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 pertaining to atypical calibration curves that can results in…
- 2022-05-25
- US
Randox Laboratories Ltd. recalls 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 Quality Controls and Patient Samples.
FDA · DeviceRandox Laboratories Ltd.Domestic distribution to WV and PR. International distribution to Bangladesh,…Official notice → - 2021-12-08
- US
Randox Laboratories Ltd. recalls 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 outside range
FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.Official notice →