Randox Laboratories Ltd. recalls
Every recall we track for Randox Laboratories Ltd. — 77 in all, from 2017–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Randox Laboratories Ltd. dropped to zero in 2025 (0, down from 7 in 2024).
All FDA recall records for Randox Laboratories Ltd. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 14 | 0 | 14 |
| 2019 | 0 | 0 | 12 | 0 | 12 |
| 2020 | 0 | 0 | 12 | 0 | 12 |
| 2021 | 0 | 0 | 4 | 0 | 4 |
| 2022 | 0 | 0 | 10 | 0 | 10 |
| 2023 | 0 | 0 | 17 | 0 | 17 |
| 2024 | 0 | 0 | 7 | 0 | 7 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Randox Laboratories Ltd. recalls
What to do if you have a recalled Randox Laboratories Ltd. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Randox Laboratories Ltd. recalls
50 shown- Lower riskMedical device
Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated
Randox recalls all CYSC Cystatin C reagents for IVD use due to missing FDA 510(k) clearance. This affects lab tests requiring the reagent. No action needed as the product is not for consumer use.
RandoxJun 7, 2024 - Lower riskMedical device
Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and
Randox recalls Evidence MultiSTAT drug testing devices with software v3.7 due to potential light leaks affecting test results. Affected units may delay reporting results.
RandoxApr 5, 2024 - Lower riskMedical device
Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38
Randox recalls Clinical Chemistry Calibration Serum (Cal2351) due to potential inorganic phosphate bias on RX Series instruments. Affected lots may cause inaccurate test results. Contact Randox for details.
RandoxMar 5, 2024 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays
Randox recalls C3 and Haptoglobin liquid protein calibrators (IT2691) used with IgA/IgG/IgM assays due to realignment to ERM-DA470k/IFCC reference material. No immediate safety risk reported.
RandoxMar 1, 2024 - Lower riskMedical device
Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated
Randox recalls specific batches of Cystatin C Calibrator (CVS 2699) due to negative bias in lab testing. Affected units may give inaccurate results for cystatin C assays.
RandoxFeb 14, 2024 - Lower riskMedical device
Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Randox recalls Microalbumin Calibrator Series (mAL:CAL) MA1567 and MA2426 due to potential misclassification of patient results. Users may see up to +12% shifts in quality control and sample recovery.
RandoxJan 31, 2024 - Lower riskMedical device
Randox Laboratories Ltd. recalls RX Series Copper (Cu) Assay Ref. Number CU2340
Randox recalls RX Series Copper (Cu) Assay Ref. CU2340 due to risk of falsely elevated copper results when run after total protein tests. Affected units have specific batch numbers.
RandoxNov 29, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351
Randox recalls Calibration Serum Level 3 CAL2351 (lot numbers 1214UE-1315UE) due to potential 13% shift in test accuracy on RX Series instruments. Affected users should contact Randox for guidance.
RandoxNov 20, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Randox recalls Calibration Serum Level 3 (CAL2351) due to misassigned Alkaline Phosphatase target causing inaccurate test results. Affected units may have errors in clinical chemistry assays.
RandoxNov 20, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level
Randox recalls Calibration Serum Level 3 (CAL 3) and Human Assayed Multi-Sera Level 2 (HN1530) due to transcription errors in instructions for bilirubin, triglycerides, and TBIC target values. Affected lots expire by November 2024 to May 2025.
RandoxNov 13, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to
Randox recalls Serology ToR: 2022 Positive Control kits due to reduced reactivity of HSV Type 1/2 lgM when tested on DiaSorin Liaison XL. Affected kits may give inaccurate results in lab tests for CMV, Rubella, Toxoplasma, and Herpes Simplex.
RandoxNov 6, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
Randox recalls Total Bilirubin test kits due to reports of inaccurate results with plasma samples. Affected kits include specific catalog numbers and all batches. No remedy is listed in the recall notice.
RandoxOct 11, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
Randox recalls RX9000 clinical chemistry analyser due to potential incorrect re-run settings causing inaccurate test results. Affected units may need correction to prevent errors in lab testing.
RandoxSep 6, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Randox recalls Liquid Assayed Chemistry Control Premium Plus Level 3 (LAE4215) due to incorrect Caeruloplasmin values in instructions. Most labs use target values safely, but misreporting risks patient errors.
RandoxAug 3, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement
Randox recalls specific batches of liquid protein calibrators due to potential 10% higher ferritin results. Affected batches include 627222, 627224, 634886, and 634887. No action is required for users.
RandoxJul 19, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium,
Randox recalls urine control kits with potential for incorrect hCG and cortisol results, causing delays in patient testing. Affected kits may have vial variations or transcription errors in instructions.
RandoxJun 21, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Randox recalls specific urea assay kits that may cause false low urea results if used immediately after LDL cholesterol tests, potentially delaying accurate patient results.
RandoxJun 13, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and
Randox recalls Immunoassay Premium Level 3 quality control kits for potential delays in test results due to high recovery values outside the acceptable range on Roche Cobas e801 analyzers.
RandoxMay 4, 2023 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical
Randox recalls specific protein control levels 2 for potential delayed test results due to reduced rheumatoid factor concentration. Affected units have catalog numbers PS2683 and GTIN 05055273204902.
RandoxNov 22, 2022 - Lower riskMedical device
Randox Laboratories Ltd. recalls IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Randox recalls IgM Immunoturbidimetric Assay (Catalog IM3834) due to potential inaccurate test results from improper use with specific fructosamine tests.
RandoxNov 1, 2022 - Lower riskMedical device
Randox Laboratories Ltd. recalls The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV
Randox recalls Serology I Positive Control vials that may test negative for HBsAg, causing delays in patient results. Affected units contain specific lot numbers and expiration dates.
RandoxAug 1, 2022 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number:
Randox recalls cholesterol test kits that may produce inaccurate results due to reduced linearity in calibration. Affected kits have specific catalog numbers and expiry dates. Consumers should contact Randox for guidance.
RandoxJun 22, 2022 - Lower riskMedical device
Randox Laboratories Ltd. recalls Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Randox recalls STFR reagents for research use only due to calibration issues with Siemens Atellica analyzers causing non-numerical results in low concentration ranges. Affected lots reported.
RandoxJun 9, 2022 - Lower riskMedical device
Randox Laboratories Ltd. recalls CK MB Calibrator, Catalogue Number CK2393
Randox recalls CK MB Calibrator model CK2393 (lot 441:0CK) due to potential 6% calibration shift affecting test accuracy. Affected units may need recalibration or replacement.
RandoxMar 25, 2022 - Lower riskMedical device
Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Randox recalls cholesterol test system (REF CH200) due to calibration errors causing high results. Affected lots from June 2022 to July 2023. No remedy stated in official notice.
RandoxNov 1, 2021 - Lower riskMedical device
Randox Laboratories Ltd. recalls NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Randox recalls NEFA CAL IVD standard (FA115) due to incorrect calibration causing up to +8% false high results in patient tests. Affected batches expire Nov 2022.
RandoxMay 10, 2021 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R
Randox recalls RX Imola Analyser with ISE models RX4900/RX4900R due to software freezing during command processing, resulting in no test results. Affected units have specific serial numbers and catalog codes.
RandoxApr 28, 2021 - Lower riskMedical device
Randox Laboratories Ltd. recalls Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
Randox recalls Calibration Serum Level 3 (CAL 3) with batch 1162UE due to potential positive bias in bilirubin tests. Affected users should check their batch numbers and contact Randox for guidance.
RandoxMar 29, 2021 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine
Randox recalls Mg R1 kits for inaccurate magnesium testing in serum/plasma/urine due to linearity issues. Affected kits may give unreliable results.
RandoxNov 13, 2020 - Lower riskMedical device
Randox Laboratories Ltd. recalls Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro
Randox recalls Lactate Dehydrogenase P-L (UV) device (LD381: LD3818) for possible test errors due to reagent carryover. Affected units may cause delayed patient results or false high readings. Contact Randox for details.
RandoxAug 11, 2020 - Lower riskMedical device
RANDOX LABORATORIES, LTD. recalls AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Randox recalls AM1015 Ammonia reagents due to potential positive bias in patient samples. This may lead to inaccurate ammonia levels in blood tests. Affected units include specific lot numbers.
RandoxJul 30, 2020 - Lower riskMedical device
RANDOX LABORATORIES, LTD. recalls Amylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 Reagent
Randox recalls specific batches of Amylase Ethylidene Blocked-pNPG7 Reagent due to performance failures before expiry. Affected units may not function correctly as intended.
RandoxJul 10, 2020 - Lower riskMedical device
RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for
Randox recalls specific Lipase Colorimetric R2 Substrate batches due to imprecision in patient sample testing. Affected units may yield inaccurate lipase test results.
RandoxJun 26, 2020 - Lower riskMedical device
Randox Laboratories Ltd. recalls Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro
Randox recalls Chemistry QC Premium Plus (LAL4213) due to incorrect sodium control target values for in vitro diagnostics. This may affect lab accuracy in diagnostic testing.
RandoxFeb 18, 2020 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Randox recalls Liquid Clinical Chemistry Control (LAE4217) due to incorrect lipase value in specific lot. This may affect lab test accuracy. No action needed for most users.
RandoxDec 13, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein
Randox recalls liquid protein calibrators (SP CAL (LIQ)) due to inaccurate Rheumatoid Factor measurements. Affected units may cause incorrect test results for certain blood tests.
RandoxAug 9, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in
Randox recalls Urinalysis Control Level 2 (UC5034) due to incorrect leukocyte range for Siemens Multistix tests. This may cause inaccurate urine test results. Affected lots: 1020UC (exp. 28 May 2020).
RandoxJul 25, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox
Rando: Randox recalls calibration serum (lot 961UE+) with potential 10% AST and 9% ALT errors affecting clinical tests. No remedy stated in official notice.
RandoxJul 12, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in
Randox recalls G-6-PDH Normal Control kits with incorrect target values for glucose-6-phosphate dehydrogenase testing. Affected lots may cause inaccurate blood test results.
RandoxApr 3, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
Randox recalls Liquid Cardiac Control models CQ5051-53 for possible NTproBNP measurement errors on Siemens Dimension EXL LOCI systems. Affected units may show lower results than expected.
RandoxMar 11, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product
Randox recalls BG5002 Blood Gas Control Level 2 due to pH range error in in-vitro diagnostics. This affects blood gas analysis quality control. No remedy specified in official notice.
RandoxFeb 13, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro
Randox recalls LIA3105 liquid immunoassay controls for inaccurate test results. The target value is listed incorrectly on the value sheet, potentially causing inaccurate lab diagnostics.
RandoxFeb 7, 2019 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Randox recalls calcium reagents that may cause false high or low test results. Affected products include specific lot codes of the Randox Calcium Colorimetric Method RX Series.
RandoxDec 4, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid
Randox recalls Fructos: 25% value decrease in calibration controls may affect test accuracy. Affected units: 500FR model for in vitro use.
RandoxDec 3, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin,
Randox recalls SP CAL (LIQ) REF IT2692 due to calibrator value sheet updates for Alpha-1-Acid-Glycoprotein and IgG tests. This affects in vitro diagnostic use with specific assays.
RandoxNov 19, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Cardiac Control, CQ5053
Randox recalls Liquid Cardiac Control CQ5053 due to unacceptable variation in Troponin T assay results. Affected units may cause inaccurate test results.
RandoxOct 2, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use,
Randox recalls Liquid Cardiac Control Level : Unacceptable variation in Troponin T assay results may delay critical cardiac marker testing. Affected lots include 4245CK.
RandoxJun 8, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
Randox recalls SP Control 2 (Cat. PS2683) due to Free Kappa light chains increasing over shelf life, potentially delaying diagnosis of monoclonal gammopathy and multiple myeloma.
RandoxMay 22, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage:
Randox recalls two lipase test kits (LI3837 and LI8361) for potential contamination in lab testing of pancreatic diseases. Affected kits may cause inaccurate results if used on medical devices.
RandoxMar 2, 2018 - Lower riskMedical device
Randox Laboratories Ltd. recalls Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is
Randox recalls HbA1c reagents (HA3830, Batch 414553) due to potential calibration issues. This may affect blood glucose testing accuracy. Affected users should contact Randox for guidance.
RandoxJun 7, 2017
Randox Laboratories Ltd. recall questions
How many recalls has Randox Laboratories Ltd. had?
77 recalls from Randox Laboratories Ltd. are on record with U.S. safety agencies, from 2017–2024.
What is the most recent Randox Laboratories Ltd. recall?
Randox Laboratories Ltd. recalls RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated, dated Jun 7, 2024. Every Randox Laboratories Ltd. recall is listed on this page, newest first.
Why are Randox Laboratories Ltd. products recalled?
The most common reasons on record: The target values and ranges in these lots are incorrect. (2).
What should I do if I have a recalled Randox Laboratories Ltd. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Randox Laboratories Ltd. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.