--- title: "Randox Laboratories Ltd. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Randox Laboratories Ltd. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/randox-laboratories-ltd/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Randox Laboratories Ltd. recall records **27** reported ongoing 35 records in this archive. Latest source date Jun 7, 2024. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 7, 2024 FDA device enforcement ### [RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004](https://isitonrecall.com/recall/fda-device-z-2425-2024-rx-series-cysc-cystatin-c-reagent-intended-for-in-vitro-diagnostic-ivd-use-as-randox-cystatin-c-assa/) Cystatin C Reagent marketed without a 510 (k) Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, GA, NY. [Official source for RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2425-2024%22) Apr 5, 2024 FDA device enforcement ### [Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115](https://isitonrecall.com/recall/fda-device-z-1786-2024-evidence-multistat-with-software-v-3-7-analyzer-intended-for-the-qualitative-determination-of-parent/) 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 will affect the testing and may delay ... Class III Reported ongoing Distribution: US Nationwide distribution. [Official source for Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of par...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1786-2024%22) Mar 5, 2024 FDA device enforcement ### [Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.](https://isitonrecall.com/recall/fda-device-z-1759-2024-clinical-chemistry-calibration-serum-catalog-number-cal2351-that-is-20x5ml-lyophilized-human-based-s/) 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. Class II Reported ongoing Distribution: Domestic: Nationwide Distribution. [Official source for Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human ba...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1759-2024%22) Mar 1, 2024 FDA device enforcement ### [Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.](https://isitonrecall.com/recall/fda-device-z-1328-2024-liquid-protein-calibrators-c3-and-haptoglobin-liquid-protein-calibrators-used-with-randox-iga-igg-an/) The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. Class II Reported ongoing Distribution: Domestic: CA, FL, IL, ME, NJ, OH, & OR. [Official source for Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, I...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1328-2024%22) Feb 14, 2024 FDA device enforcement ### [Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699](https://isitonrecall.com/recall/fda-device-z-1369-2024-cystatin-c-calibrator-in-vitro-diagnostic-ivd-use-in-the-calibration-of-the-randox-cystatin-c-assay/) Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, IN. [Official source for Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1369-2024%22) Jan 31, 2024 FDA device enforcement ### [Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567](https://isitonrecall.com/recall/fda-device-z-1593-2024-microalbumin-calibrator-series-malb-cal-ivd-used-to-calibrate-the-microalbumin-assay-catalog-number/) 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 recovery of up to +12%. Class II Reported ongoing Distribution: US Nationwide distribution in the states of GA, MA, WV including PR. [Official source for Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Nu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1593-2024%22) Jan 31, 2024 FDA device enforcement ### [Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426](https://isitonrecall.com/recall/fda-device-z-1594-2024-microalbumin-calibrator-series-malb-cal-ivd-to-calibrate-the-microalbumin-assay-catalog-number-ma242/) 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 and patient sample recovery of up to +12%. Class II Reported ongoing Distribution: US Nationwide distribution in the states of GA, MA, WV including PR. [Official source for Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number:...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1594-2024%22) Nov 29, 2023 FDA device enforcement ### [RX Series Copper (Cu) Assay Ref. Number CU2340](https://isitonrecall.com/recall/fda-device-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, on the RX series instruments testing order. If copper assay is run after total protein it could ... Class II Reported ongoing Distribution: US Nationwide distribution in the states of SC and OK. [Official source for RX Series Copper (Cu) Assay Ref. Number CU2340](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0992-2024%22) Nov 20, 2023 FDA device enforcement ### [Calibration Serum Level 3 CAL2351](https://isitonrecall.com/recall/fda-device-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 Control and patient sample recovery of up to 13%. Class II Reported ongoing Distribution: US Nationwide and Puerto Rico. [Official source for Calibration Serum Level 3 CAL2351](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0752-2024%22) Nov 20, 2023 FDA device enforcement ### [Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351](https://isitonrecall.com/recall/fda-device-z-0753-2024-calibration-serum-level-3-ivd-for-use-as-a-calibrator-in-clinical-chemistry-assays-catalog-number-ca/) 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 Class II Reported ongoing Distribution: US Nationwide including Puerto Rico. [Official source for Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Numb...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0753-2024%22) Nov 13, 2023 FDA device enforcement ### [Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)](https://isitonrecall.com/recall/fda-device-z-0751-2024-calibration-serum-level-3-cal-3-ref-cal2351-human-assayed-multi-sera-level-2-hn1530-human-assayed-mu/) 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 Assayed Multi-Sera Level 2 (HN1530) for TBI... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human As...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0751-2024%22) Nov 6, 2023 FDA device enforcement ### [SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, Ig...](https://isitonrecall.com/recall/fda-device-z-0624-2024-serology-torch-lgm-2022-positive-controli-intended-for-use-with-in-vitro-assays-for-determination-of/) 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 III Reported ongoing Distribution: NY, WV [Official source for SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0624-2024%22) Oct 11, 2023 FDA device enforcement ### [RANDOX Total Bilirubin.](https://isitonrecall.com/recall/fda-device-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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AR, GA, NC, TN, & PR. [Official source for RANDOX Total Bilirubin.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0501-2024%22) Sep 6, 2023 FDA device enforcement ### [RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040](https://isitonrecall.com/recall/fda-device-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 assay range and may result i issues with the re-run feature conditions when incorrectly. Potential... Class II Reported ongoing Distribution: US Nationwide distribution including Puerto Rico [Official source for RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0198-2024%22) Sep 6, 2023 FDA device enforcement ### [RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)](https://isitonrecall.com/recall/fda-device-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 assay range and may result i issues with the re-run feature conditions when incorrectly. Potential... Class II Reported ongoing Distribution: US Nationwide distribution including Puerto Rico [Official source for RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0199-2024%22) Sep 6, 2023 FDA device enforcement ### [RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)](https://isitonrecall.com/recall/fda-device-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 assay range and may result i issues with the re-run feature conditions when incorrectly. Potential... Class II Reported ongoing Distribution: US Nationwide distribution including Puerto Rico [Official source for RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0200-2024%22) Sep 6, 2023 FDA device enforcement ### [RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000](https://isitonrecall.com/recall/fda-device-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 assay range and may result i issues with the re-run feature conditions when incorrectly. Potential... Class II Reported ongoing Distribution: US Nationwide distribution including Puerto Rico [Official source for RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0201-2024%22) Sep 6, 2023 FDA device enforcement ### [RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000](https://isitonrecall.com/recall/fda-device-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 assay range and may result i issues with the re-run feature conditions when incorrectly. Potential... Class II Reported ongoing Distribution: US Nationwide distribution including Puerto Rico [Official source for RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0202-2024%22) Aug 3, 2023 FDA device enforcement ### [Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215](https://isitonrecall.com/recall/fda-device-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 one and two standard deviation values printed on the sheet are incorrect, which may lead to misrepo... Class II Reported ongoing Distribution: US States: GA, OH, OR, PA, TX, VA [Official source for Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2609-2023%22) Jul 19, 2023 FDA device enforcement ### [Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealb...](https://isitonrecall.com/recall/fda-device-z-2448-2023-randox-liquid-protein-calibrators-sp-cal-liq-in-vitro-diagnostic-product-used-for-the-calibration-of/) 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 calibrators lots 2112IT-2116IT, packed into... Class II Reported ongoing Distribution: CA, FL, IL, ME, MI, NC, OH, PA,NJ, [Official source for Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibrati...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2448-2023%22) ## Reasons in these listed records - Cystatin C Reagent marketed without a 510 (k) - 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 will affect the testing and may delay in reporting results. - 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. - The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC. These examples come from this result page and are not a ranking of every recall reason. ## Checking Randox Laboratories Ltd. ### Is there a recall on randox laboratories ltd. right now? This archive contains 35 records, including 27 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Randox Laboratories Ltd.](https://isitonrecall.com/check/?q=Randox%20Laboratories%20Ltd.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)